Number of 483 issued from the System*

Inspections ending between 10/1/2005 12:00:00 AM and 9/30/2006 12:00:00 AM

Center Name 483 issued

Foods 2452
Devices 887
Drugs 649
Incidental text 418
Biologics 299
Bioresearch monitoring 286
Parts 1240 and 1250 204
Veterinary medicine 202
Human tissue for transplantation 86
Special requirements 12
Radiological health 2

Sum Product Area 483s from System* 5497

Actual Total in system 483s** 4849

* This table does not represent the complete set of 483's issued
during the fiscal year as some 483's were manually prepared and not
available in this format. The sum of 483's for all Product Areas will be
greater than the actual Total 483's issued during the fiscal year since
a 483 may include citations related to multiple product areas, and
counted more than once, under each relevant product center.

** This is the Actual Total number of 483's issued from this system,
and that are represented in this spreadsheet.
0 AM
Center Name Cite Id Ref No Short Desc

Biologics 76 21 CFR 606.100(b) Maintained and followed

98 21 CFR 606.100(c) Thorough investigations

4425 21 CFR 606.60(a) Equipment observed, standardized, calibrated

155 21 CFR 606.160(b) Required records

160 21 CFR 606.160(a)(1) Person performing, test results, interpretation

9225 21 CFR 606.171 Biological product deviation report

154 21 CFR 606.160(a)(1) Concurrent documentation

31 21 CFR 606.20(b) Qualifications of responsible personnel

161 21 CFR 606.160(a)(2) Determination of lot numbers and supplies

67 21 CFR 606.65(e) Following manufacturer's instructions

77 21 CFR 606.100(b) Written SOPs available for use by personnel

78 21 CFR 606.100(c) Record review prior to release

94 21 CFR 606.100(b)(15) Schedules and procedures for equipment &

calibration

208 21 CFR 640.3(a)(1) Donor suitability procedures not followed

 9044 21 CFR 600.10(b) Personnel capabilities

50 21 CFR 606.40(c) Provide adequate handwashing

57 21 CFR 606.60(a) Maintain and clean equipment

89 21 CFR 606.100(b)(10) Controlling storage temperatures

159 21 CFR 606.160(a)(1) Legibility and indelibility

227 21 CFR 640.4(h) Storage temperatures after collection

9089 21 CFR 600.14(c) When to report

12202 21 CFR 606.170(a) Adverse Reaction - Investigations

224 21 CFR 640.4(f) Arm preparation

9086 21 CFR 600.14(a)(1) Who must report - manufacturer

12203 21 CFR 606.170(a) Adverse Reaction- Reports of Investigations

65 21 CFR 606.65(c) Testing of representative samples of reagent

lots

150 21 CFR 606.151(e) Procedures to maintain records of emergency

transfusions

255 21 CFR 640.31 Donor suitability

9220 21 CFR 606.100(b)(20) Donor notification

 93 21 CFR 606.100(b)(14) QC procedures for supplies and reagents

142 21 CFR 606.140(a) Establishment of spec., standards, and test

procedures

165 21 CFR 606.170(a) Adverse reaction - Maintenance of Reports

88 21 CFR 606.100(b)(9) Written methods for investigating adverse

reactions

143 21 CFR 606.140(b) Provisions to monitor lab test procedures &

instruments

167 21 CFR 606.170(b) Adverse reaction - fatality

41 21 CFR 606.40(a)(1) Provide space for examination

61 21 CFR 606.60(a) Provide proper equipment to meet

requirements

9087 21 CFR 600.14(a)(1) Who must report - receiving information

9219 21 CFR 606.100(b)(20) Donor deferral

9227 21 CFR 606.171(a) BPDR - procedures

9596 21 CFR 640.3(a) Donor suitability by means of medical history

35 21 CFR 606.40 Clean & orderly

75 21 CFR 606.100(a) SOP compliance

80 21 CFR 606.100(b)(1) Donor criteria

 84 21 CFR 606.100(b)(5) Accurate measurement of quantity of blood

85 21 CFR 606.100(b)(6) Methods of component preparation

156 21 CFR 606.160(c) Assignment of donor number

158 21 CFR 606.160(e) Unsuitable donors

206 21 CFR 640.3(a) Donor suitability determined by unqualified

person

207 21 CFR 640.3(a) Donor suitability not performed on day of

collection

215 21 CFR 640.3(b)(6) Qualifications of donor - disease transmissible

by blood

333 21 CFR 640.64(e) Prevention of contamination

9052 21 CFR 600.11(b) Equipment

9240 21 CFR 630.6(d)(1) Physician notification

43 21 CFR 606.40(a)(3) Provide space for storage of blood & blood

products

46 21 CFR 606.40(a)(6) Provide space for quarantine of unsuitable for

use items

81 21 CFR 606.100(b)(2) Donor qualifying tests & measurements

82 21 CFR 606.100(b)(3) Preparation of phlebotomy site

117 21 CFR 606.121(f) Labeling of blood products unsuitable for

transfusion
 162 21 CFR 606.165(a) Distribution and receipt - recalls

211 21 CFR 640.3(b)(2) Qualifications of donor - blood pressure

246 21 CFR 640.25(a) Storage temps./agitation

251 21 CFR 640.25(b) Quality control

368 21 CFR 640.72(d) Donor reaction

376 21 CFR 640.120 Alternative procedures

3438 21 CFR 600.15 Temperatures during shipment

3543 21 CFR 610.46(a)(1) Quarantine and notification

9077 21 CFR 600.12(a) Maintenance - completeness

9223 21 CFR 606.160(b)(6) Required records - transfusion reaction and

complaints

9238 21 CFR 630.6(b)(3) Results of testing

9264 21 CFR 610.40(d)(4) Autologous donation - label

9288 21 CFR 640.21 Suitability of donor

36 21 CFR 606.40 Suitable size, construction, etc.

45 21 CFR 606.40(a)(5) Provide space for storage of finished product

 63 21 CFR 606.65 Safe, sanitary, orderly storage

69 21 CFR 606.65(a) Surfaces are sterile, pyrogen free, and non-

reactive

86 21 CFR 606.100(b)(7) Methods for performance of all tests

87 21 CFR 606.100(b)(8) Methods for pre-transfusion testing

91 21 CFR 606.100(b)(12) Criteria for suitability of reissue of returned

blood

92 21 CFR 606.100(b)(13) Procedures to relate blood from donor to final

disposition

95 21 CFR 606.100(b)(16) Labeling procedures to avoid labeling mix-ups

108 21 CFR 606.120(c) Legibility of labels

111 21 CFR 606.120(b)(3) Utilization of labeling checks

121 21 CFR 606.121(c)(2) Name, address, registration number

124 21 CFR 606.121(c)(5) Paid or volunteer donor statement

144 21 CFR 606.140(c) Adequate identification and handling of test

samples

163 21 CFR 606.165(b) Distribution records - content

205 21 CFR 640.3(f) Donations in less than eight weeks

212 21 CFR 640.3(b)(3) Qualifications of donor - hemoglobin

 221 21 CFR 640.4(c) Blood containers and donor sets

238 21 CFR 640.11(a) General requirements - storage

241 21 CFR 640.11(b) General requirements - inspection

260 21 CFR 640.31(b) Criteria for plasmapheresis donor suitability

313 21 CFR 640.63(e) Failure to return red blood cells

321 21 CFR 640.63(c)(6) Weight

329 21 CFR 640.64(a) Supervision

366 21 CFR 640.72(b) Cross reference of donor record to unit of

plasma

3248 21 CFR 640.63(a) Determining donor suitability

3252 21 CFR 640.63(a) Determination not made on day of collection

3443 21 CFR 610.47 Notification of transfusion recipients

3451 21 CFR 601.22 Products in Short Supply

3452 21 CFR 601.12(b) Major changes to an approved application

3498 21 CFR 640.91(c) Microbial contamination

3544 21 CFR 610.46(a)(2) Quarantine by consignee

3618 21 CFR 606.100(b)(19) Procedure for HIV lookback

9006 21 CFR 606.100(b)(19) Notification of attending physicians

9051 21 CFR 600.11(a) Work areas - temperatures

9097 21 CFR 600.15 Blood & Blood Components

9235 21 CFR 630.6(c) Documentation

9236 21 CFR 630.6(b)(1) Deferred or not suitable

9256 21 CFR 610.41 Donor Deferral

9262 21 CFR 610.40(b) Approved screening tests

9271 21 CFR 610.41 Donor Deferral - reentry

9275 21 CFR 640.4(g)(5) Anticoagulant

9285 21 CFR 640.16(a) Separation

Long Desc

Written standard operating procedures including all steps to be followed in the [collection] [processing] [compatibility testing] [storage]
[distribution] of blood and blood components for [homologous transfusion] [autologous transfusion] [further manufacturing purposes] are not
always [maintained] [followed] [maintained on the premises]. Specifically, ***

Failure to [perform a thorough investigation] [make a record of the conclusions and follow-up] of [an unexplained discrepancy] [a failure of a
lot or unit to meet any of its specifications]. Specifically,***

Equipment used in the [collection] [processing] [compatibility testing] [storage and distribution] of blood and blood components is not
[observed] [standardized] [calibrated] on a regularly scheduled basis as prescribed in the SOP Manual. Specifically, ***

Failure to maintain [donor] [processing] [storage and distribution] [compatibility testing] [quality control] [general] records. Specifically, ***

Records fail to [identify the person performing the work] [include dates of the various entries] [show test results] [include interpretation of the
results] [show the expiration date assigned to specific products] [be as detailed as necessary] so as to provide a complete history of the
work performed. Specifically, ***

Failure to submit a biological product deviation report [within 45 days from the date you acquired information suggesting that a reportable
event occurred]. Specifically, ***

Records are not concurrently maintained with the performance of each significant step in the [collection] [processing] [compatibility testing]
[storage] [distribution] of each unit of blood and blood components so that all steps can be clearly traced. Specifically, ***

The personnel responsible for the [collection] [processing] [compatibility testing] [storage] [distribution] of blood or blood components are not
adequate in [number] [educational background] [training and experience, including professional training as necessary] to assure competent
performance of their assigned functions, and to ensure that the final product has the safety, purity, potency, identity and effectiveness it
purports or is represented to possess. Specifically, ***

Appropriate records are not available to determine the lot numbers of [supplies] [reagents] used for specific [lots] [units] of the final product.
Specifically, ***

Failure to use supplies and reagents in a manner consistent with instructions provided by the manufacturer. Specifically, ***

Failure to make available written procedures for use by personnel in the areas where the procedures are performed. Specifically, ***

All records pertinent to a lot or unit were not reviewed before the release or distribution of a lot or unit of final product. Specifically, ***

The standard operating procedure fails to include a written description of schedules and procedures for equipment maintenance and
calibration. Specifically, ***

Failure to [follow] [maintain] [maintain on the premises] standard procedures and methods for determining the suitability of a donor as a
source of blood. Specifically, ***
Failure to assure that personnel have [capabilities commensurate with] [the necessary training in] [necessary experience in] [a thorough
understanding of] the operations which they perform. Specifically, ***

Failure to provide [adequate] [clean] [convenient] handwashing facilities for personnel. Specifically, ***

Failure to [maintain] [locate] equipment used in the [collection] [processing] [compatibility testing] [storage] [distribution] of blood and blood
products [in a clean and orderly manner] [so as to facilitate cleaning and maintenance]. Specifically, ***

The standard operating procedure fails to include a written description of the storage temperatures and methods of controlling storage
temperatures for all blood products and reagents Specifically, ***

Records are [illegible] [not indelible]. Specifically, ***

After collection, blood is not [immediately stored at a temperature between 1 and 6 degrees Celsius] [transported from the donor clinic to the
processing laboratory in temporary storage to cool the blood continuously toward a range between 1 and 6 degrees Celsius]. Specifically,
***

Biological product deviations [were] [are] not reported within the 45 calendar day timeframe. Specifically, ***

A thorough investigation of each reported adverse reaction was not made. Specifically,

The phlebotomy site is not prepared by a method that gives maximum assurance of a sterile container of Whole Blood. Specifically, ***

Failure to submit [a] biological deviation [report] [reports]. Specifically, ***

Written reports of investigations of adverse reactions, including conclusions and follow up, are not prepared and maintained. Specifically,

Representative samples of each lot of [Anti-human globulin] [Blood grouping reagents] [Lectins] [Antibody screening and reverse grouping
cells] [Hepatitis test reagents] [Syphilis serology reagents] [Enzymes] are not tested on a regularly scheduled basis as described in the SOP
Manual to determine their capacity to perform as required by the regulations. Specifically, ***

Records [including signature by the physician requesting the procedure] are not maintained of all emergency transfusions [including
complete documentation justifying the emergency action]. Specifically, ***

Failure to ensure that [whole blood] [plasmapheresis] donors meet suitability criteria. Specifically, ***

The standard operating procedure fails to include a written description of the [donor notification process] [process for follow-up if the initial
attempt at donor notification fails]. Specifically, ***
The standard operating procedure fails to include a written description of the quality control procedures for supplies and reagents employed
in [blood collection] [processing] [pretransfusion testing]. Specifically, ***

Failure to establish scientifically sound and appropriate specifications, standards and test procedures to assure that blood and blood
components are safe, pure, potent and effective. Specifically, ***

Failure to maintain reports of complaints of adverse reactions regarding each unit of blood or blood product arising as a result of [blood
collection] [transfusion]. Specifically, ***

The standard operating procedure fails to include a written description of the procedures for investigating adverse donor and recipient
reactions. Specifically, ***

Failure to establish adequate provisions for monitoring the [reliability] [accuracy] [precision] [performance] of laboratory test procedures and
instruments. Specifically, ***

A confirmed, fatal complication of [blood collection] [transfusion] was not [reported as soon as possible] [submitted in writing within 7 days
after the fatality] to the Director, Office of Compliance, Center for Biologics Evaluation and Research by the [collecting facility in the event of
a donor reaction] [facility that performed the compatibility tests in the event of a transfusion reaction]. Specifically, ***

Failure to provide adequate space for [private] [accurate] examinations of individuals to determine their suitability as blood donors.
Specifically, ***

Failure of equipment to perform in the manner for which it was designed so as to assure compliance with the official requirements
prescribed in 21 CFR 606. Specifically, ***

Failure to [establish] [maintain] [follow] procedures for obtaining information on all [deviations] [complaints] [adverse events] for a distributed
biological product subject to biological product deviation reporting. Specifically, ***

The standard operating procedure fails to include a written description of the donor deferral process. Specifically, ***

Failure to establish a procedure to obtain information about [deviations] [complaints] [adverse events] from your contractor. Specifically, ***

Failure to [always] determine donor suitability on the day of collection by means of [medical history] [test for hemoglobin level] [physical
examination]. Specifically, ***

Failure to maintain facilities in a clean and orderly manner. Specifically, ***

Failure of the Standard Operating Procedure to comply with additional standards in 21 CFR 640. Specifically, ***

The standard operating procedure fails to include written descriptions of criteria used to determine donor suitability, including acceptable
medical history criteria. Specifically, ***
The standard operating procedure fails to include a written description of the blood collection procedure, including in-process precautions
taken to measure accurately the quantity of blood removed from the donor. Specifically, ***

The standard operating procedure fails to include written descriptions of the methods for component preparation, including any time
restrictions for specific steps in processing. Specifically, ***

Failure of records describing the history and ultimate disposition of blood products to include a donor number [assigned to each accepted
donor] [which relates to the unit of blood collected from that donor] [which relates to the donor's medical record] [which relates to any
component or blood product from the donor's unit of blood]. Specifically, ***

A record is not available from which unsuitable (deferred) donors may be identified so that products from such individuals will not be
distributed. Specifically, ***

Failure to determine the suitability of a donor as a source of blood by a qualified physician or by a person under his supervision and trained
in determining suitability. Specifically, ***

Failure to determine the suitability of a donor as a source of blood by a qualified physician or by a trained person under his supervision on
the day of collection. Specifically, ***

Failure to determine whether each donor is free from any disease transmissible by blood as determined by history and examinations.
Specifically, ***

The phlebotomy site is not prepared by a method that gives maximum assurance of a sterile container of blood. Specifically, ***

There is no assurance that equipment is [adequately sterilized] [properly cleaned] [inspected for cleanliness] [suitable for use]. Specifically,
***

Failure to provide to an autologous donor's referring physician [information that the autologous donor is deferred based on the results of
tests for evidence of infection due to communicable disease agents, and the reason for that decision] [the types of donation of blood and
blood components that the autologous donor should not donate in the future] [the results of tests for evidence of infection due to
communicable disease agent(s) that were a basis for deferral] [results of any supplemental tests]. Specifically, ***

Failure to provide adequate space for the storage of blood or blood components pending completion of tests. Specifically, ***

Failure to provide adequate space for the [quarantine] [storage] [handling] [disposition] of [products] and [reagents] not suitable for use.
Specifically, ***

The standard operating procedure fails to include written descriptions of methods for performing donor qualifying tests and measurements,
including minimum and maximum values for a test or procedure when a factor in determining acceptability. Specifically, ***

The standard operating procedure fails to include written descriptions of solutions and methods used to prepare the site of phlebotomy to
give maximum assurance of a sterile container of blood. Specifically, ***

Failure to prominently label blood and blood components (except for recovered plasma) determined to be unsuitable for transfusion with
["NOT FOR TRANSFUSION"] [the reason the unit is considered unsuitable]. Specifically, ***
Failure of distribution and receipt procedures to include a system by which the distribution or receipt of each unit can be readily determined
to facilitate its recall. Specifically, ***

Each donor was not in good health as indicated in part by systolic and diastolic blood pressures which were not within normal limits and the
examining physician has not determined that this individual with blood pressures outside these limits is otherwise qualified as a donor.
Specifically, ***

Failure to store platelets immediately after resuspension [at 20 to 24 degrees Celsius with continuous gentle agitation] [at 1 to 6 degrees
Celsius]. Specifically, ***

Failure to test each month (of manufacture) four units prepared from different donors at the end of the storage period for [platelet count] [pH
of not less than 6.0 measured at the storage temperature of the unit] [actual plasma volume]. Specifically, ***

Failure of the donor record to contain a full explanation of a donor reaction, while on the plasmapheresis premises or reported to the center
after the donor has left the premises, including the measures taken to assist the donor and the outcome of the incident. Specifically, ***

Failure to request from CBER and obtain approval for exceptions or alternatives to requirements regarding [blood] [blood components]
[blood products]. Specifically, ***

Failure to maintain temperatures during shipment of [Fresh Frozen Plasma at -18 degree C or colder] [Cryoprecipitated AHF at -18 degree C
or colder] [Liquid Plasma at 1 to 10 degree C] [Plasma at -18 degree C or colder] [Platelets as close as possible to a range between 20 to 24
degree C] [ Red Blood Cells and Whole Blood between 1 and 10 degree C] [Red Blood Cells, Frozen at -65 degree or colder] [Source
Plasma at -5 degree C or colder] [Source Plasma Liquid at 10 degree C or colder]. Specifically, ***

When a donor tested repeatedly reactive for antibody to human immunodeficiency virus or otherwise was determined to be unsuitable when
tested in accordance with the regulations, you did not take appropriate action within 72 hours to [institute a quarantine] [notify your
consignee(s) for the purpose of instituting a quarantine] of [whole blood] [blood components] [source plasma] [source leukocytes] collected
from the donor. Specifically, ***

The [manufacturing] [distribution] records [are not legible and indelible] [do not detail the various steps of manufacture of the product].
Specifically, ***

Failure to maintain records of transfusion reaction reports and complaints, including investigation and follow up. Specifically, ***

Failure to notify the donor of the results of [tests for evidence of infection due to communicable disease agents that were a basis for deferral]
[supplemental tests]. Specifically, ***

Failure to label autologous donations with the [name of the donor] [identifying information of the donor] [appropriate caution statement].
Specifically, ***

All [plasmapheresis] [plateletpheresis] donors did not meet the criteria for suitability. Specifically, **

Failure to provide facilities of suitable [size] [construction] [location] so as to facilitate adequate cleaning, maintenance and proper
operations. Specifically, ***

Failure to provide adequate space for the storage of finished products prior to distribution. Specifically, ***
Failure to store all supplies and reagents used in the [collection] [processing] [compatibility testing] [storage] [distribution] of blood and blood
components in a safe, sanitary and orderly manner. Specifically, ***

Failure to ensure that all surfaces coming in contact with blood and blood components intended for transfusion are [sterile] [pyrogen-free]
[do not interact with the product in such a manner as to have an adverse effect upon the safety, purity, potency or effectiveness of the
product]. Specifically, ***

The standard operating procedure fails to include a written description of all tests and repeat tests performed on blood and blood
components during processing. Specifically, ***

The standard operating procedure fails to include a written description of pretransfusion testing, where pretransfusion testing is applicable,
including precautions to be taken to identify accurately the recipient blood samples and crossmatched donor units. Specifically, ***

The standard operating procedure fails to include a written description of the criteria for determining whether returned blood is suitable for
reissue. Specifically, ***

The standard operating procedure fails to include a written description of the procedures used for relating a unit of blood or blood
component from the donor to its final disposition. Specifically, ***

The standard operating procedure fails to [include a written description of the labeling procedures] [include safeguards to avoid labeling mix-
ups]. Specifically, ***

Failure to utilize clear and legible labeling. Specifically, ***

Failure to utilize all necessary checks in labeling procedures to prevent errors in translating test results to container labels. Specifically, ***

The container label fails to include the [name] [address] [registration number] [the license number of each manufacturer, for a licensed
product]. Specifically, ***

The container label of the blood product intended for transfusion fails to include the appropriate donor classification statement, i.e., "paid
donor" or "volunteer donor." Specifically, ***

Failure to adequately provide for identification and handling of all test samples so that they are accurately related [to the specific unit of
product being tested] [to its donor] [to the specific recipient]. Specifically, ***

Distribution records fail to contain information to readily facilitate identification of [the name and address of the consignee] [the date and
quantity delivered] [the lot number of the unit(s)] [the date of expiration or date of collection] [the name of the recipient for crossmatched
blood and blood components]. Specifically, ***

A person served as a source of blood more than once in 8 weeks and was not examined at the time of donation and certified by a physician
to be in good health as indicated in part in 21 CFR 640.3(b). Specifically, ***

Each donor was not in good health as indicated in part by the blood hemoglobin level which was demonstrated to be less than 12.5 gm. of
hemoglobin per 100 ml of blood (38% by microhematocrit). Specifically, ***
The [blood containers] [donor sets] are not [pyrogen-free] [sterile] [identified by lot number] [water repellent when used for processing
Heparin Whole Blood]. Specifically, ***

Failure to [store] [maintain] the Red Blood Cells between 1 and 6 degrees Celsius immediately after processing. Specifically, ***

Failure to [inspect Red Blood Cells immediately after separation of the plasma, periodically during storage, and at the time of issue] [prevent
issuance if Red Blood Cells are abnormal in color, physical appearance, or indicative of microbial contamination]. Specifically, ***

Failure of a plasmapheresis donor to [meet the same criteria for donor suitability as specified for Source Plasma donors (21 CFR 640.63)]
[be presented the informed consent]. Specifically, ***

Failure to defer each donor for eight weeks who has [not had the red blood cells returned from a unit of blood] [been a donor of a unit of
whole blood]. Specifically, ***

Donor did not weigh 110 pounds or more on the date of donation. Specifically, ***

Failure to draw blood from a donor for the collection of Source Plasma by a physician or trained persons under his supervision trained in the
procedure. Specifically, ***

Failure to directly cross-reference each donor record to the unit(s) of the Source Plasma associated with the donor. Specifically, ***

Failure to have donor suitability determined [by a qualified licensed physician or trained persons under his supervision]. Specifically, ***

Determination of the suitability of Source Plasma donors was not made on the day of collection. Specifically, ***

Failure to [notify the attending physician of a recipient of a lookback unit] [make a minimum of three attempts within 8 weeks to notify the
recipient of a lookback unit in the event the physician does not inform the recipient] [notify recipient's legal representative or relative]
[document notifications of lookback units]. Specifically, ***

Failure of manufacturer to establish that persons/places who conduct initial, and partial manufacturing of a product for shipment solely to
such manufacturer are [registered with FDA] [in full compliance with the applicable regulations of this subchapter related to continued safety,
purity and potency]. Specifically, ***

Failure to [submit a supplement] [receive supplement approval from FDA] prior to distributing product made using the change. Specifically,
***

Processing [step] [steps] not conducted in a manner to minimize the risk of contamination. Specifically, ***

When you were notified that a donor had tested repeatedly reactive for antibody to human immunodeficiency virus or otherwise had been
determined to be unsuitable when tested in accordance with the regulations, you did not take appropriate action to quarantine [whole blood]
[blood components] [source plasma] [source leukocytes] collected from the donor. Specifically, ***
There is no written procedure to look at prior donations of Whole Blood, blood components, Source Plasma, and Source Leukocytes, when
a donor of blood subsequently tests repeatedly reactive for antibody to human immunodeficiency virus, or otherwise is determined to be
unsuitable when tested in accordance with the applicable regulations. Specifically, ***

The written procedures for HIV "lookback" fail to include procedures in accordance with 21 CFR 610.47 to notify attending physicians so that
transfusion recipients are informed that they may have received [Whole Blood] [blood components] at increased risk for transmitting HIV.
Specifically, ***

The [refrigerators] [incubators] [temperature controlled rooms] [are not maintained at the required temperatures] [are not free of extraneous
material that may affect the safety of the product]. Specifically, ***

Failure to maintain temperatures during shipment of [Fresh Frozen Plasma at -18 °C or colder] [Cryoprecipitated AHF at -18 °C or colder]
[Liquid Plasma at 1 to 10 °C] [Plasma at -18 °C or colder] [Platelets as close as possible to the labeled range] [Platelet Rich Plasma as close
as possible to the labeled range] [Red Blood Cells between 1 and 10 °C] [Red Blood Cells, Frozen at -65 °C or colder] [Source Plasma at -5
°C or colder] [Source Plasma Liquid at 10 °C or colder] [Whole Blood as required]. Specifically, ***

Failure to [document that you have successfully notified a deferred donor] [document that you have made reasonable attempts to notify a
deferred donor]. Specifically, ***

Failure to notify the donor [that the donor is deferred or determined not to be suitable] [of the reason for deferral]. Specifically, ***

Failure to defer a donor who tested reactive [by a screening test for evidence of infection due to a communicable disease agent] [for a
serological test for syphilis] from further donations of human blood and blood components. Specifically, ***

Blood or blood components were not tested for evidence of infection due to communicable disease agents [using screening tests that the
FDA has approved for such use][in accordance with the manufacturer's instructions]. Specifically, ***

The method or process used to requalify deferred donors was not found acceptable for such purposes by FDA. Specifically, ***

All segments for compatibility testing did not contain blood mixed with appropriate anticoagulant. Specifically, ***

Failure to prepare Red Blood Cells [in the time frame specified in the directions for use for the system used] [by centrifugation, in a manner
that will not tend to increase the temperature of the blood]. Specifically, ***
Frqncy

168

44

37

35

34

27

22

20

18

16

13

13

13

13
12

11

10

10

10

7
6

3
3

2
2

1
1

1
1

1
1

1
Center Name Cite Id Ref No Short Desc

Bioresearch 7560 21 CFR 312.60 FD-1572, protocol compliance

monitoring

7530 21 CFR 312.62(b) Case history records- inadequate or inadequate

7526 21 CFR 312.62(a) Accountability records

7318 21 CFR 56.115(a)(2) Minutes of IRB meetings

7227 21 CFR 50.27(a) Consent form not approved/signed/dated

7281 21 CFR 56.108(a)(1) Initial and continuing reviews

7290 21 CFR 56.108(c) Members present for review

7498 21 CFR 312.66 Unanticipated problems

7342 21 CFR 56.108(b)(2) Prompt reporting of noncompliance

7334 21 CFR 56.115(a)(5) List of members

7231 21 CFR 50.20 Consent not obtained, exceptions do not apply

7562 21 CFR 312.60 Informed consent

7293 21 CFR 56.109(f) Continuing review

7321 21 CFR 56.110(c) Method to keep members advised

7552 21 CFR 312.66 Changes in research

7278 21 CFR 56.107(e) Conflict of interest

7286 21 CFR 56.108(b)(1) Prompt reporting of unanticipated problems

7335 21 CFR 56.115(a)(6) Written procedures per 56.108(a) and (b)

7343 21 CFR 56.108(b)(3) Reporting of suspension/termination

7317 21 CFR 56.115(a)(1) Copies of all research proposals and related

documents

7482 21 CFR 312.50 General responsibilities of sponsors

7340 21 CFR 56.108(a)(3) Prompt reporting of changes

7391 21 CFR 50.25(a)(5) Confidentiality, FDA inspection of records

4006 21 CFR 58.120(b) Protocol: approval of changes

7368 21 CFR 56.108(a)2) More frequent reviews, verification of no changes

7369 21 CFR 56.109(h) Children as subjects

7390 21 CFR 50.25(a)(4) Alternate procedures, courses of treatment

7517 21 CFR 312.66 Initial and continuing review

7520 21 CFR 312.64(b) Safety reports

3956 21 CFR 58.63(c) Equipment: maintenance records

7316 21 CFR 56.115(a)(4) Copies of IRB/CI correspondence

7320 21 CFR 56.109(e) IRB approvals/disapprovals - general

7371 21 CFR 56.108(a)(1) Reporting findings and actions to

investigator/institution

7527 21 CFR 312.62(a) Unused drug disposition (investigator)

7652 21 CFR 56.113 Reporting

7654 21 CFR 56.110(b) Research not eligible for expedited review

3914 21 CFR 58.31(f) Management: personnel understand their

functions

3923 21 CFR 58.33(f) Study director: transfer of data to archives

3931 21 CFR 58.35(b)(5) QAU: authorize deviations from protocols or

SOPs

3951 21 CFR 58.51 Facility: archives

3952 21 CFR 58.61 Equipment: appropriate design and adequate

capacity

3960 21 CFR 58.81(b) SOPs: required

3977 21 CFR 58.90(g) Animal care: analysis of feed and water

3997 21 CFR 58.120(a)(4) Protocol: test system description

4007 21 CFR 58.130(a) Conduct: in accordance with protocol

7279 21 CFR 56.107(f) Invited individual allowed to vote with IRB

7319 21 CFR 56.115(a)(3) Records of continuing review

7353 21 CFR 50.52 Factors required for approval

7370 21 CFR 56.111(c) Children as subjects

7392 21 CFR 50.25(a)(7) Whom to contact

7459 21 CFR 312.57(a) Records of receipt, shipment, disposition

7480 21 CFR 312.50 Ensuring compliance with plan and protocol

7488 21 CFR 312.59 Records of unused drug disposition

7531 21 CFR 312.62(c) Record retention

3918 21 CFR 58.33(a) Study director: follow study protocol

3920 21 CFR 58.33(c) Study director: unforeseen circumstances

3926 21 CFR 58.35(b)(1) QAU: maintain a master schedule

3932 21 CFR 58.35(b)(6) QAU: review final study report

3953 21 CFR 58.63(a) Equipment: inspection, cleaning and

maintenance
3954 21 CFR 58.63(a) Equipment: calibration

3958 21 CFR 58.81(a) SOPs: authorization and documentation of

deviations

3999 21 CFR 58.120(a)(6) Protocol: experimental design

4012 21 CFR 58.130(e) Conduct: date and sign

4016 21 CFR 58.185(a) Final report: non-existent

4037 21 CFR 58.190(b) Archives: conditions of storage

7324 21 CFR 56.111(a)(4) Informed consent sought

7638 21 CFR 312.20(a) Failure to submit an IND

7664 21 CFR 50.20 Circumstances of obtaining consent

7666 21 CFR 50.20 Understandable language

3903 21 CFR 58.29(b) Personnel: summary of training, job description

3911 21 CFR 58.31(c) Management: assure there is a QAU

3925 21 CFR 58.35(a) QAU: separate and independent

3957 21 CFR 58.81(a) SOPs: laboratory methods

3959 21 CFR 58.81(a) SOPs: authorized changes

3978 21 CFR 58.90(g) Animal care: feed and water analysis records

3983 21 CFR 58.105(a) Test article: characterization

3985 21 CFR 58.105(b) Test article: stability

3989 21 CFR 58.107 Test article: handling

4018 21 CFR 58.185(a)(2) Final report: objectives, procedures, changes

4020 21 CFR 58.185(a)(4) Final report: data on test and control articles

4021 21 CFR 58.185(a)(5) Final report: stability of test and control articles

4025 21 CFR 58.185(a)(9) Final report: circumstances affecting data qual.,

integrity

4028 21 CFR 58.185(a)(12) Final report: reports of individual scientists

4035 21 CFR 58.190(a) Archives: data, documentation, specimens

7274 21 CFR 56.107(a) At least five members with varying backgrounds

7297 21 CFR 56.109(b) Information given to subjects

7305 21 CFR 56.110(b)(2) Minor changes

7309 21 CFR 56.111(a)(1) Risks minimized by sound research design

7325 21 CFR 56.111(a)(5) Informed consent documented

7372 21 CFR 56.115(b) Access to records

7387 21 CFR 50.25(a)(1) Statement of research, purpose, duration of

participation

7388 21 CFR 50.25(a)(2) Reasonably foreseeable risks or discomforts

7411 21 CFR 312.53(c)(1) Investigator statement (FDA 1572)

7555 21 CFR 312.53(d) Selecting monitors

7650 21 CFR 56.113 Authority of the IRB

7656 21 CFR 56.108(c) Approval from a majority of members present

3900 21 CFR 58.10 Notifying contractor of GLP status

3902 21 CFR 58.29(a) Personnel: education, training, experience

3904 21 CFR 58.29(c) Personnel: sufficient number

3909 21 CFR 58.31(a) Management: designating the study director

3912 21 CFR 58.31(d) Management: testing of test and control articles

3917 21 CFR 58.33 study director: overall study responsibility

3919 21 CFR 58.33(b) Study director: all data recorded and verified

3922 21 CFR 58.33(e) Study director: follow GLP regulations

3924 21 CFR 58.35(a) QAU: monitor facilities, etc.

3928 21 CFR 58.35(b)(3) QAU: inspect study at adequate intervals

3933 21 CFR 58.35(b)(7) QAU: signed statement in final report

3934 21 CFR 58.35(c) QAU: SOPs and required records

3936 21 CFR 58.41 Facility: suitable size and construction

3946 21 CFR 58.47(a)(1) Facility: article receipt and storage areas

3955 21 CFR 58.63(b) Equipment: maintenance SOPs

3962 21 CFR 58.81(d) SOPs: historical file

3963 21 CFR 58.83 Reagents: labeling

3976 21 CFR 58.90(f) Animal care: cage and equipment cleaning

3990 21 CFR 58.113(a)(1) Mixtures: uniformity and concentration

3992 21 CFR 58.113(c) Mixtures: expiration dating

3993 21 CFR 58.120(a) Protocol: approved

4000 21 CFR 58.120(a)(7) Protocol: diet description

4004 21 CFR 58.120(a)(11) Protocol: date and signature

4008 21 CFR 58.130(b) Conduct: test systems monitoring

4011 21 CFR 58.130(e) Conduct: recording in ink

4017 21 CFR 58.185(a)(1) Final report: name, address, dates

4022 21 CFR 58.185(a)(6) Final report: description of methods

4023 21 CFR 58.185(a)(7) Final report: description of test system

4024 21 CFR 58.185(a)(8) Final report: dosage, regimen, route of admin.,

duration

4026 21 CFR 58.185(a)(10) Final report: names of those involved

4027 21 CFR 58.185(a)(11) Final report: operations on data, analysis of data

4031 21 CFR 58.185(b) Final report: not signed by study director

4040 21 CFR 58.190(d) Archives: unauthorized personnel

4041 21 CFR 58.190(e) Archives: indexing, expedient retrieval

4044 21 CFR 58.195(d) Archives: maintenance of records by QAU

4047 21 CFR 58.195(g) Archives: records not retained as originals, true

copies

7209 21 CFR 50.25(a)(1) Procedures, identification of those which were

experimental

7233 21 CFR 50.23(a) Two written certifications re: no IC

7270 21 CFR 56.103(a) IRB review requirement

7277 21 CFR 56.107(d) One non-affiliate member

7304 21 CFR 56.110(b)(1) No more than minimal risk

7313 21 CFR 56.112 Approval by institution in absence of IRB approval

7322 21 CFR 56.111 (a)(2) Risks to subjects reasonable

7333 21 CFR 56.104(c) Emergency use and IRB approval

7337 21 CFR 56.115(b) Retention of records

7339 21 CFR 56.108(a)(4) Changes in approved research

7352 21 CFR 50.51 Provisions for soliciting assent and permission

7354 21 CFR 50.53 Factors required for approval

7363 21 CFR 50.55(f) Documentation of permission by parents or

guardian

7367 21 CFR 50.55(e)(2) Two parents' permission: studies under Parts

50.53 - 50.54

7383 21 CFR 50.25(b)(6) Number of subjects in study

7389 21 CFR 50.25(a)(3) Benefits to the subject

7393 21 CFR 50.25(a)(8) Participation; refusal and discontinuance

7406 21 CFR 56.109(a) Scope of reviews

7453 21 CFR 312.56(b) Investigator non-compliance

7479 21 CFR 312.56(a) Monitoring investigations

7507 21 CFR 312.52(a) Transfer of obligations

7519 21 CFR 312.64(c) Final study report

7533 21 CFR 312.69 Controlled substances (investigator)

7543 21 CFR 312.61 Unauthorized recipients (investigator)

7545 21 CFR 312.120(c) Foreign clinical trials

7632 21 CFR 312.6(a) Required label statement

7634 21 CFR 312.7(a) Promotion of Investigational Drug

7639 21 CFR 312.20(b) Starting a study before IND is in effect

7665 21 CFR 50.20 Exculpatory language, waiving of rights

Long Desc

An investigation was not conducted in accordance with the [signed statement of investigator] [investigational plan]. Specifically***

Failure to prepare or maintain [adequate] [accurate] case histories with respect to [observations and data pertinent to the investigation]
[informed consent]. Specifically, ***

Investigational drug disposition records are not adequate with respect to [dates] [quantity] [use by subjects]. Specifically, ***

Minutes of IRB meetings have not been [prepared] [maintained] in sufficient detail to show [attendance at the meetings] [actions taken by the
IRB] [the vote on actions, including the number of members voting for, against and abstaining] [the basis for requiring changes in or
disapproving research] [a written summary of the discussion of controverted issues and their resolution]. Specifically, ***

Informed consent was not properly documented in that the written informed consent used in the study [was not approved by the IRB] [was
not signed by the subject or the subject’s legally authorized representative at the time of consent ] [was not dated by the subject or the
subject's legally authorized representative at the time of consent]. Specifically, ***

The IRB [has no] [did not follow its] written procedure for conducting its [initial] [continuing] review of research. Specifically, ***

For other than expedited reviews, the IRB does not always review proposed research at convened meetings at which a majority of the
members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. Specifically, ***

Failure to report promptly to the IRB all unanticipated problems involving risk to human subjects or others. Specifically, ***

The IRB [has no] [did not follow] written procedures for ensuring prompt reporting to [the IRB] [appropriate institutional officials] [the FDA] of
any instance of serious or continuing noncompliance with theses regulations or the requirements or determinations of the IRB. Specifically,
***

A list of IRB members has not been [prepared] [maintained], identifying members by [name] [earned degrees] [representative capacity]
[indications of experience sufficient to describe each member's chief anticipated contribution to IRB deliberations] [any employment or other
relationship between each member and the institution]. Specifically, ***

Legally effective informed consent was not obtained from a subject or the subject's legally authorized representative, and the situation did
not meet the criteria in 21 CFR 50.23 - 50.24 for exception. Specifically, ***

Failure to obtain informed consent in accordance with 21 CFR Part 50 from each human subject prior to [drug administration] [conducting
study-related tests] . Specifically***

The IRB does not conduct continuing review of research at intervals [appropriate to the degree of risk] [of not less than once per year].
Specifically, ***

The IRB uses an expedited review procedure, but [has not adopted] [is not following] a method for keeping members advised of research
proposals which have been approved under the procedure. Specifically, ***
Not all changes in research activity were approved by an Institutional Review Board prior to implementation. Specifically, ***

The IRB allowed a member to participate in the IRB's [initial] [continuing review] of a project in which the member had a conflicting interest.
Specifically, ***

The IRB [has no] [did not follow] written procedures for ensuring prompt reporting to [the IRB] [appropriate institutional officials] [the FDA] of
any unanticipated problems involving risks to human subjects or others. Specifically, ***

Documentation has not been [prepared] [maintained] of written procedures for the IRB, as required by 21 CFR 56.108(a) and (b).
Specifically, ***

The IRB [has no] [did not follow] written procedures for ensuring prompt reporting to [the IRB] [appropriate institutional officials] [the FDA] of
any suspension or termination of IRB approval . Specifically, ***

Copies have not been [prepared] [maintained] of all [research proposals reviewed] [scientific evaluations, if any, accompanying research
proposals] [approved sample consent documents] [progress reports submitted by investigators] [reports of injuries to subjects]. Specifically,
***

Failure to [select qualified investigators] [provide investigators with the information needed to conduct the study properly] [ensure proper
monitoring of the study] [ensure the study is conducted in accordance with the protocol and/or investigational plan] [ensure that FDA and all
investigators are promptly informed of significant new adverse effects or risks]. Specifically, ***

The IRB [has no] [did not follow its] written procedure for ensuring prompt reporting to the IRB of changes in research activity. Specifically,
***

There was no statement in the informed consent document that [described the extent, if any, to which confidentiality of records identifying
the subject would be maintained] [noted the possibility that the Food and Drug Administration might inspect the records]. Specifically, ***

Not all changes in, or revisions of, an approved protocol and the reasons therefore were documented, signed by the study director, dated,
and maintained with the protocol. Specifically, ***

The IRB [has no] [did not follow its] written procedure for determining which projects [require review more often than annually] [need
verification from sources other than the investigator that no material changes have occurred since previous IRB review] . Specifically, ***

The IRB did not determine [at the time of initial review] [at the time of continuing review for an on-going study which was started on/before
April 30, 2001] that a study was in compliance with 21 CFR Part 50 Subpart D, "Additional Safeguards for Children in Clinical
Investigations." Specifically, ***

There was [no] [an incomplete] disclosure in the informed consent document of appropriate alternate procedures or courses of treatment, if
any, that might be advantageous to the subject. Specifically, ***

Failure to assure that an IRB [complying with applicable regulatory requirements] was responsible for the initial and continuing review and
approval of a clinical study. Specifically, ***

Failure to report [promptly] to the sponsor adverse effects that may reasonably be regarded as caused by, or probably caused by, an
investigational drug. Specifically, ***
Adequate written records are not maintained of all equipment inspection, maintenance, testing, calibrating and/or standardizing operations.
Specifically, ***

Copies have not been maintained of all correspondence between the IRB and the investigators. Specifically, ***

The IRB has not promptly notified in writing [the investigator] [the institution] when the IRB has [approved] [disapproved] [required
modifications to secure IRB approval of] proposed research activity. Specifically, ***

The IRB [has no] [did not follow its] written procedure for reporting its [findings] [actions] to the [investigator] [institution]. Specifically, ***

Unused supplies of an investigational drug were not [returned to the sponsor] [disposed of in accordance with sponsor instructions].
Specifically, ***

The IRB's [suspension] [termination of approval] for research was not reported [promptly] to [the investigator] [appropriate institutional
officials] [the Food and Drug Administration]. Specifically, ***

The IRB used an expedited review procedure for research which did not appear in an FDA list of categories eligible for expedited review,
and which had not previously been approved by the IRB [within one year]. Specifically, ***

Testing facility management failed to assure that all personnel clearly understood the functions they were to perform. Specifically, ***

The study director failed to assure that all raw data, documentation, protocols, specimens, and final reports were transferred to the archives
during or at the close of the study. Specifically, ***

The quality assurance unit failed to determine whether any deviations from approved protocols or standard operating procedures had been
made with proper authorization and documentation. Specifically, ***

Space is not provided for archives, limited to access by authorized personnel only, for the storage and retrieval of all raw data and
specimens from completed studies. Specifically, ***

Not all [equipment used in the generation, measurement, or assessment of data] [equipment used for facility environmental control] is of
appropriate design and adequate capacity to function according to the protocol and is suitably located for operation, inspection, cleaning,
and maintenance. Specifically, ***

Standard operating procedures have not been established for [animal room preparation] [animal care] [receipt, identification, storage,
handling, mixing, and method of sampling of the test and control articles] [test system observations] [laboratory tests] [handling of animals
found moribund or dead during study] [necropsy of animals or postmortem examination of animals] [collection and identification of
specimens] [histopathology] [data handling, storage, and retrieval] [maintenance and calibration of equipment] [transfer, proper placement,
and identification of animals]. Specifically, ***
Not all animal feed and water were analyzed periodically to ensure that expected contaminants were not present at levels above those
specified in the protocol. Specifically, ***

Not all protocols contained the number, body weight range, sex, source of supply, species, strain, substrain, and age of the test system.
Specifically, ***
Not all nonclinical laboratory studies were conducted in
accordance with the protocol. Specifically, ***

The IRB invited an individual with competence in a special area to assist in the review of complex issues which required expertise beyond or
in addition to that available on the IRB; however, the IRB allowed the individual to vote with the IRB. Specifically, ***

Records have not been [prepared] [maintained] of all continuing review activities. Specifically, ***

The IRB approved a clinical investigation in which more than minimal risk to children was presented by 1) an intervention or procedure that
held out the prospect of direct benefit for the individual subjects, and/or 2) by a monitoring procedure which was likely to contribute to the
individual subjects' well-being. However, the IRB did not [find] [document] that [the risk was justified by the anticipated benefit to the
subjects] [the relation of the anticipated benefit to the risk was at least as favorable to the subjects as that presented by available alternative
approaches] [adequate provisions had been made for soliciting the assent of the children and the permission of their parents or guardians,
as set
The forth
IRB in 21 CFR
approved the 50.55].
conductSpecifically,
of research ***
involving children as subjects, but did not determine that the research was in compliance with 21
CFR 50 Subpart D. Specifically, ***

The informed consent document lacked an explanation of whom to contact [for answers to pertinent questions about the research and
research subjects' rights] [in the event of a research-related injury to the subject]. Specifically, ***

Lack of [adequate] records covering [receipt] [shipment to investigators] [disposition] of an investigational drug. Specifically, ***

Failure to ensure that an investigation was conducted in accordance with the general investigational plan and protocols as specified in the
IND. Specifically, ***

Failure to maintain [adequate] written records of the disposition of an investigational drug in accordance with 21 CFR Part 312.57.
Specifically, ***

Investigational records were not retained for a period of two years following [approval of a drug's marketing application] [discontinuance of
the investigation and notification of FDA]. Specifically, ***

The study director failed to assure that the protocol, including any change, was approved and was followed. Specifically, ***

The study director failed to assure that unforeseen circumstances that might affect the quality and integrity of the nonclinical laboratory study
were noted when they occurred and corrective action was taken and documented. Specifically, ***

The quality assurance unit failed to maintain a copy of a master schedule sheet that contained all required elements for all nonclinical
laboratory studies conducted by the testing facility. Specifically, ***

The quality assurance unit failed to review the final study report to assure that such report accurately described the methods and standard
operating procedures, and that the reported results accurately reflected the raw data of the study. Specifically, ***

Not all equipment is adequately inspected, cleaned, and maintained. Specifically, ***
Not all equipment used for the generation, measurement, or assessment of data is adequately tested, calibrated and/or standardized.
Specifically, ***

Not all deviations from standard operating procedures in a study were authorized by the study director and documented in the raw data.
Specifically, ***

Not all protocols contained a description of the experimental design, including the methods for the control of bias. Specifically, ***

Not all data entries were dated on the date of entry and signed or initialed by the person entering the data. Specifically, ***

A final report was not prepared for each nonclinical laboratory study. Specifically, ***

Conditions of storage failed to minimize deterioration of the [documents] [specimens] in accordance with the requirements for the time
period of their retention and the nature of the [documents] [specimens]. Specifically, ***

The IRB approved the conduct of research, but did not determine that informed consent would be sought from each prospective subject or
the subject's legally authorized representative, to the extent required by 21 CFR 50. Specifically, ***

The sponsor failed to submit an IND to the FDA prior to conducting a clinical investigation with an investigational new drug. Specifically,***

The general requirements for informed consent were not met in that [you] [the investigator] did not seek consent under circumstances that
[provided the prospective subject or the subject's representative sufficient opportunity to consider whether or not to participate] [minimized
the possibility of coercion or undue influence]. Specifically, ***

The general requirements for informed consent were not met in that the information given was not in language understandable to the
subject or the subject's representative. Specifically, ***

The testing facility failed to maintain a current summary of training and experience and job description for each individual engaged in or
supervising the conduct of a nonclinical laboratory study. Specifically, ***

Testing facility management failed to assure that there was a quality assurance unit in conformance with FDA GLP regulations. Specifically,
***

The quality assurance unit, for any given study, was not entirely separate from and independent of the personnel engaged in the direction
and conduct of that study. Specifically, ***

The testing facility does not have written standard operating procedures setting forth nonclinical laboratory study methods that management
is satisfied are adequate to insure the quality and integrity of the data generated in the course of a study. Specifically, ***

Not all significant changes in established standard operating procedures were properly authorized in writing by management. Specifically,
***
Not all feed and water analyses for contaminants were maintained as raw data. Specifically, ***.

The identity, strength, purity, composition, or other characteristics of each batch of test and control article have not been appropriately
defined and documented. Specifically, ***

The stability of each test or control article was not determined by the testing facility or by the sponsor before study initiation, or concomitantly
according to written standard operating procedures which provide for periodic analysis of each batch. Specifically, ***

Procedures have not been established for the handling of the test and control articles to ensure that [there is proper storage] [distribution is
made in a manner designed to preclude the possibility of contamination, deterioration, or damage] [proper identification is maintained
throughout the distribution process] [the receipt and distribution of each batch is documented including the date and quantity of each batch
distributed or returned]. Specifically, ***

The final study report did not include the objectives and procedures stated in the approved protocol, including any changes in the original
protocol. Specifically, ***

The final study report did not include the test and control articles identified by name, chemical abstracts number or code number, strength,
purity, and composition or other appropriate characteristics. Specifically, ***

The final study report did not include the stability of the test and control articles under the conditions of administration. Specifically, ***

The final study report did not include a description of all circumstances that may have affected the quality or integrity of the data.
Specifically, ***

The final study report did not include the signed and dated reports of each of the individual scientists or other professionals involved in the
study. Specifically, ***

Not all [raw data] [documentation] [protocols] [final reports] [specimens (except those specimens obtained from mutagenicity tests and wet
specimens of blood, urine, feces, and biological fluids)] generated as a result of a nonclinical laboratory study were retained. Specifically, ***

The IRB is not composed of at least five members [with varying backgrounds to promote complete and adequate review of research
activities commonly conducted by the institution]. Specifically, ***

The IRB does not require that information given to subjects as part of informed consent contain all necessary elements of informed consent.
Specifically, ***:

The IRB used an expedited review procedure to review supposedly minor changes to previously-approved research, but the changes were
not minor in nature. Specifically, ***

The IRB approved the conduct of research, but did not determine that risks to subjects were minimized by using procedures which were
consistent with sound research design and which did not unnecessarily expose subjects to risk. Specifically, ***

The IRB approved the conduct of research, but did not determine that informed consent would be appropriately documented. Specifically,
***
Records required to be maintained under 21 CFR 56 were not accessible for [inspection] [copying] by authorized representatives of the
FDA. Specifically, ***

The informed consent document did not contain [a statement that the study involved research] [an explanation of the purposes of the
research, and the expected duration of the subject's participation]. Specifically, ***

The informed consent document lacked a description of reasonably foreseeable risks or discomforts to the subject. Specifically, ***

Failure to obtain [an] [a complete] investigator statement, form FDA-1572, before permitting an investigator to participate in an investigation.
Specifically, ***

Monitors not qualified by experience and training were selected to monitor the progress of a clinical investigation. Specifically, ***

The IRB lacks authority to [suspend] [terminate approval of] research that is not being conducted in accordance with the IRB's requirements
or that has been associated with unexpected serious harm to subjects. Specifically, ***

For other than expedited reviews, research approved by the IRB does not always receive the approval of a majority of those IRB members
present. Specifically, ***

Not all consulting laboratories, contractors, or grantees were notified that the study must be conducted in compliance with FDA GLP
regulations. Specifically, ***

Not all individuals engaged in the conduct of or responsible for the supervision of a nonclinical laboratory study have education, training, and
experience, or combination thereof, to enable that individual to perform assigned functions. Specifically, ***

The testing facility did not have a sufficient number of personnel for the timely and proper conduct of the study according to the protocol.
Specifically, ***

Testing facility management failed to designate a study director before each study was initiated. Specifically, ***

Testing facility management failed to assure that all test and control articles or mixtures had been appropriately tested for identity, strength,
purity, stability, and uniformity, as applicable. Specifically, ***

The study director did not have overall responsibility for the technical conduct of the study as well as for the interpretation, analysis,
documentation and reporting of results, and does not represent the single point of study control. Specifically, ***

The study director failed to assure that all experimental data, including observations of unanticipated responses of the test system, were
accurately recorded and verified. Specifically, ***

The study director failed to assure that all applicable GLP regulations were followed. Specifically, ***
The quality assurance unit did not monitor each study to assure management that the facilities, equipment, personnel, methods, practices,
records, and controls were in conformance with FDA GLP regulations. Specifically, ***

The quality assurance unit failed to inspect each nonclinical laboratory study at intervals adequate to assure the integrity of the study and
maintain written and properly signed records of each periodic inspection. Specifically, ***

The quality assurance unit failed to prepare and sign a statement to be included with the final study report which specified the dates
inspections were made and findings reported to management and to the study director. Specifically, ***

The quality assurance unit failed to maintain and make available for inspection required records regarding its responsibilities and
procedures and the method of indexing such records. Specifically, ***

The testing facility is not of suitable size and construction to facilitate the proper conduct of nonclinical laboratory studies. Specifically, ***

The testing facility does not provide separate areas, as necessary, to prevent contamination or mix-ups for receipt and storage of the test
and control articles. Specifically, ***

The standard operating procedures for routine inspection, cleaning, maintenance, testing, calibration, and/or standardization of equipment
are not adequate. Specifically, ***

A historical file of standard operating procedures, and all revisions, including the dates of such revisions, was not maintained. Specifically,
***

Not all reagents and solutions in the laboratory areas are labeled to indicate identity, titer or concentration, storage requirements, and
expiration date. Specifically, ***

Not all animal cages, racks and accessory equipment were cleaned and sanitized at appropriate intervals. Specifically, ***

Not all test or control articles mixed with a carrier were tested by appropriate analytical methods to determine [the uniformity of the mixture]
[periodically, the concentration of the test or control article in the mixture]. Specifically, ***

Not all test or control article carrier mixtures [had an expiration date clearly shown on the container] [consisting of more than one
component, had the earliest expiration date clearly shown on the container]. Specifically, ***

Not all studies had an approved written protocol that clearly indicated the objectives and all methods for the conduct of the study.
Specifically, ***

Not all protocols contained a description and/or identification of the diet used in the study. Specifically, ***

Not all protocols contained the date of approval of the protocol by the sponsor and the dated signature of the study director. Specifically, ***
Not all test systems were monitored in conformity with the protocol. Specifically, ***

Data generated without the use of an automated data collection system were not recorded directly, promptly, and legibly in ink. Specifically,
***

The final study report did not include the name and address of the facility performing the study and the dates on which the study was
initiated and completed. Specifically, ***

The final study report did not include a description of the methods used. Specifically, ***

The final study report did not include a description of the test system used and, where applicable, the number of animals used, sex, body
weight range, source of supply, species, strain and substrain, age, and procedure used for identification. Specifically, ***

The final study report did not include a description of the dosage, dosage regimen, route of administration, and duration. Specifically, ***

The final study report did not include [the name of the study director] [the names of other scientists or professionals] [the names of all
supervisory personnel] involved in the study. Specifically, ***

The final study report did not include [a description of the transformations, calculations, or operations performed on the data] [a summary
and analysis of the data] [a statement of the conclusions drawn from the analysis]. Specifically, ***

Not all final reports were signed and dated by the study director. Specifically, ***

Unauthorized personnel entered the archives. Specifically, ***

Not all material retained or referred to in the archives was indexed to permit expedient retrieval. Specifically, ***

Not all master schedules, copies of protocols, and records of quality assurance inspections were maintained by the quality assurance unit as
an easily accessible system of records for the required period of time. Specifically, ***

Not all required records were retained as original records or as true copies of the original records. Specifically, ***

The informed consent document did not contain [a description of the procedures to be followed] [identification of any procedures which were
experimental]. Specifically, ***

A test article was used without informed consent being obtained from a research subject. The investigator and a physician who was not
otherwise participating in the investigation did not both certify in writing that [the human subject was confronted by a life-threatening situation
necessitating the use of the test article] [informed consent could not be obtained from the subject because of an inability to communicate
with, or obtain legally effective consent from, the subject] [time was not sufficient to obtain consent from the subject's legal representative]
[there was no alternative method of approved or generally recognized therapy available that would provide an equal or greater likelihood of
saving the life of the subject]. Specifically, ***
A clinical investigation requiring prior submission to the FDA was initiated without [IRB review] [IRB approval] [being subject to continuing
IRB review]. Specifically, ***

The IRB does not include at least one member who is not otherwise affiliated with the institution, and who is not part of the immediate family
of a person who is affiliated with the institution. Specifically, ***

The IRB used an expedited review procedure for research appearing in an FDA list of categories eligible for expedited review, but the
reviewer did not find the research involved no more than minimal risk to the subjects. Specifically, ***

The institution approved research which had not been approved by the IRB. Specifically, ***

The IRB approved the conduct of research, but did not determine that the risks to subjects were reasonable in relation to the anticipated
benefits (if any) to subjects, and to the importance of the knowledge that might be expected to result. Specifically, ***

A clinical investigator did not report to the IRB [, within five days of use,] the emergency use of a test article for which the IRB had not
reviewed the research proposal. Specifically, ***

Records required by 21 CFR 56 have not been maintained for three years following completion of the research. Specifically, ***

The IRB [has no] [did not follow its] written procedure for ensuring that changes in approved research, during the periods for which IRB
approval had already been given, would not be initiated without IRB review and approval (except where necessary to eliminate apparent
immediate hazards to the human subjects). Specifically, ***

For a clinical investigation in which no greater than minimal risk to children as subjects was presented, the IRB did not [find] [document] that
adequate provisions had been made for [soliciting the assent of the children] [soliciting the permission of the parents or guardians of the
children] as set forth at 21 CFR 50.55. Specifically, ***

The IRB approved a study in which more than minimal risk to children was presented by [an intervention or procedure that did not hold out
the prospect of direct benefit for the subjects] [a monitoring procedure that was not likely to contribute to the well-being of the subjects].
However, the IRB did not [find] [document] that [the risk represented a minor increase over minimal risk] [the intervention or procedure
presented experiences to subjects that were reasonably commensurate with those inherent in their actual or expected medical, dental,
psychological, social, or educational situations] [the intervention or procedure was likely to yield generalizable knowledge about the subjects'
disorder or condition
Permission by parentsthat
or was of vitalfor
guardians importance for the of
the participation understanding or amelioration
children as subjects of the
in a clinical subjects' disorder
investigation was notordocumented
condition] [adequate
in accordance
provisions
with and tohad
the been
extentmade for soliciting
required by 21 CFR the50.27.
assentSpecifically,
of the children
*** and permission of their parents or guardians]. Specifically, ***

For a clinical investigation involving children, conducted under [21 CFR 50.53] [21 CFR 50.54], the investigator did not always obtain the
permission of both parents where feasible. Specifically, ***

The informed consent document did not state the approximate number of subjects involved in the study. Specifically, ***

A description of any benefits [to the subject] [to others] which might reasonably be expected from the research was not included in the
informed consent document. Specifically, ***

The informed consent document did not contain a statement that [participation was voluntary] [refusal to participate would involve no penalty
or loss of benefits to which the subject was otherwise entitled] [the subject might discontinue participation at any time without penalty or loss
of benefits to which the subject was otherwise entitled]. Specifically, ***
The IRB does not review all research activities covered by the regulations. Specifically, ***

An investigator who did not comply with [the signed agreement] [the general investigational plan] [applicable regulatory requirements] was
not [promptly brought into compliance] [terminated]. Specifically, ***

Failure to monitor the progress of an investigation conducted under your IND. Specifically, ***

Transfer of obligations to a contract research organization [was not described in writing] [did not describe each of the obligations assumed
by the contract research organization, where not all obligations were assumed]. Specifically, ***

An adequate final report was not provided to the sponsor shortly after completion of the investigator's participation in the investigation.
Specifically, ***

Inadequate precautions to prevent theft or diversion with respect to [storage of] [access to] an investigational drug which is a controlled
substance. Specifically, ***

A study drug was [administered to subjects] [provided to persons] not under the investigator's personal supervision or under the supervision
of a subinvestigator responsible to the investigator. Specifically, ***

Failure to assure that foreign clinical research was conducted in accordance with [the ethical principles stated in the ``Declaration of
Helsinki''] [the laws and regulations of the country in which the research was conducted]. Specifically, ***

The immediate package of the investigational new drug does not bear a label with the statement "Caution: New Drug- Limited by Federal (or
United States) law to investigational use

Representations were made in a promotional context that the investigational drug is [safe] [effective] for the purposes for which it is under
investigation. Specifically, ***

The sponsor began a clinical investigation subject to IND requirements before an IND was in effect. Specifically,***

The general requirements for informed consent were not met in that the consent form contained exculpatory language [through which the
subject or the subject's representative was made to waive or appear to waive some of the subject's legal rights] [that released or appeared
to release the investigator, sponsor, the institution, or its agents from liability for negligence]. Specifically, ***
Frqncy

128

77

30

29

26

26

18

18

15

14

13

13

10

10
10

6
5

4
4

3
3

2
2

2
2

1
1

1
1

1
1

1
1

1
Center Name Cite Id Ref No Short Desc

Devices 4189 21 CFR 820.198(a) General

3130 21 CFR 820.100(a) Procedures - general

3696 21 CFR 820.100(b) Lack of documentation of CAPA activities

630 21 CFR 803.17 Lack of Written MDR Procedures

546 21 CFR 820.75(a) General

4058 21 CFR 820.20 Management responsibility

2327 21 CFR 820.22 Quality audit procedures

2371 21 CFR 820.30(a) Design control procedures

3666 21 CFR 820.20(c) Management review procedures

3415 21 CFR 820.22 Quality audits conducted

447 21 CFR 820.40 Document control procedures

3291 21 CFR 820.100(b) Procedures

3172 21 CFR 820.198(c) Investigation of device failures

3837 21 CFR 820.25(b) Training documentation

3233 21 CFR 820.72(a) Calibration, inspection, equipment control
procedures

3103 21 CFR 820.30(i) Design changes - procedures prior to

implementation

3125 21 CFR 820.80(d) Procedures, finished devices

3118 21 CFR 820.75(a) Documentation - general

538 21 CFR 820.70(a) Process control procedures

3687 21 CFR 820.100(a)(1) Analysis of data sources

3371 21 CFR 820.198(a)(3) Processing MDRs {see also 803, 804}

479 21 CFR 820.50 Purchasing control procedures

3282 21 CFR 820.90(a) Nonconforming product control procedures

3690 21 CFR 820.100(a)(3) Identification of actions needed

3155 21 CFR 820.181(a) DMR device specifications

3160 21 CFR 820.184 Establishing device history record procedures

2302 21 CFR 820.20(e) Quality System Procedures

486 21 CFR 820.50(a) Evaluation of suppliers, contractors and consultants

2974 21 CFR 812.110(b) Investigator non-compliance with

agreement/plan/regulations
2968 21 CFR 812.100 Investigator non-compliance with
agreement/plan/regulations

732 21 CFR 803.50(a)(2) Report of Malfunction

3669 21 CFR 820.20(c) Management reviews at defined intervals

3299 21 CFR 820.100(a)(1) Procedure for analysis of data sources

3167 21 CFR 820.198(a) Complete files maintained

3692 21 CFR 820.100(a)(4) CAPA verification/validation of corrective/preventive

action

3678 21 CFR 820.30(g) Risk analysis

3369 21 CFR 820.198(a)(1) Uniform and timely processing

3120 21 CFR 820.80(a) General

541 21 CFR 820.70(c) Environmental control

3665 21 CFR 820.20(b)(3) Management representative

3121 21 CFR 820.80(b) Receiving acceptance procedures

2351 21 CFR 820.25(b) Training

2350 21 CFR 820.25(b) Training - Lack of or inadequate procedures

731 21 CFR 803.50(a)(1) Report of Death or Serious Injury

14505 21 CFR 812.140(a)(3) Investigator's subject records inadequate

4059 21 CFR 820.22 Quality audits - effectiveness of quality system

3127 21 CFR 820.80(e) Documentation

3288 21 CFR 820.90(b)(1) Documentation of disposition, justification,

signature

3164 21 CFR 820.184(d) Acceptance records

3283 21 CFR 820.90(a) Specific non-conforming product procedures

3117 21 CFR 820.70(i) Software validation for automated processes

3433 21 CFR 820.75(c) Process changes - review, evaluation and

revalidation

3284 21 CFR 820.90(a) Nonconforming product evaluation/investigation

3201 21 CFR 820.40(a) Not approved or obsolete document retrieval

3199 21 CFR 820.40(a) Document review, approval documentation

2293 21 CFR 820.20(d) Quality plan

3688 21 CFR 820.100(a)(1) Analysis of data/reports from data sources

3301 21 CFR 820.100(a)(2) Investigation procedures

3416 21 CFR 820.70(a)(1) Process control instructions

3332 21 CFR 820.184(e) ID label, labeling

3159 21 CFR 820.184 DHR content - general

3104 21 CFR 820.30(j) Design history file

537 21 CFR 820.70(a) Production processes

3101 21 CFR 820.30(g) Design validation procedures

2328 21 CFR 820.22 Quality audits, auditor independence

4191 21 CFR 806.10(a)(1) Report of risk to health

3689 21 CFR 820.100(a)(2) Investigation

3380 21 CFR 820.198(e)(6) Results of investigation

3250 21 CFR 820.72(b)(2) Calibration documentation

3119 21 CFR 820.75(b) Monitoring and control of validated processes

3268 21 CFR 820.80(b) Incoming inspection, testing, verification

3128 21 CFR 820.90(a) Nonconforming product control

2628 21 CFR 820.30(e) Design review procedures - personnel

2269 21 CFR 820.20(a) Quality policy established

4070 21 CFR 820.30(g) Design validation documentation, DHF {see also
820.30(j)}

3677 21 CFR 820.30(g) Design validation of device software

3304 21 CFR 820.100(a)(5) Changes to correct/prevent quality problems

3102 21 CFR 820.30(h) Design transfer

3226 21 CFR 820.70(g)(1) Schedule

2981 21 CFR 812.140(a)(2)(i) Investigator device accountability inadequate

2650 21 CFR 820.30(f) Design verification

2648 21 CFR 820.30(f) Design verification procedures

2429 21 CFR 820.30(b) Establish the design and development plan

3303 21 CFR 820.100(a)(4) Verify, validate change {see also 820.100(a)}

3285 21 CFR 820.90(b)(2) Product rework procedures

3157 21 CFR 820.181(c) DMR QA procedures and specifications

3132 21 CFR 820.120 Labeling procedures - general

3680 21 CFR 820.70(a) Process control procedure content

3427 21 CFR 820.50(a)(2) Supplier oversight

3345 21 CFR 820.200(a) Procedures established

3286 21 CFR 820.90(b)(1) Procedures for product review, disposition

3156 21 CFR 820.181(b) DMR production process specifications

2984 21 CFR 812.140(a)(3)(i) Investigator records of informed consent

inadequate

4212 21 CFR 806.20(b)(4) Justification for not reporting

3302 21 CFR 820.100(a)(3) Identifying corrective & preventive actions

3231 21 CFR 820.70(i) Documentation of software validation

3123 21 CFR 820.80(c) Procedures

539 21 CFR 820.70(b) Production and process change procedures

3681 21 CFR 820.70(b) Verification or validation of changes

3417 21 CFR 820.70(a)(2) Production monitoring and control

3276 21 CFR 820.80(e) Maintained as part of the DHR {see also 820.184}

3270 21 CFR 820.80(c) Documentation

3151 21 CFR 820.180 Legibility

3021 21 CFR 812.150(a)(1) Investigator report of unanticipated adverse effects

2604 21 CFR 820.30(e) Design review procedures - general

540 21 CFR 820.70(b) Production and process changes - failure to follow

procedure

3686 21 CFR 820.90(b)(2) Product rework documentation, DHR {see also

820.184}

3683 21 CFR 820.70(g) Installation, placement qualification

3426 21 CFR 820.50(a)(1) Documenting evaluation

3269 21 CFR 820.80(b) Incoming acceptance records, documentation

3170 21 CFR 820.198(b) Review and evaluation for investigation

3108 21 CFR 820.70(e) Contamination control procedures

2557 21 CFR 820.30(c) Design input documentation

3702 21 CFR 820.250(a) Appropriateness

3676 21 CFR 820.30(f) Design verification documentation, DHF {see also

820.30(j)}

3428 21 CFR 820.50(a)(3) Acceptable supplier records

3262 21 CFR 820.250(a) Establish procedures for identifying statistical

techniques

3207 21 CFR 820.50(b) Supplier notification of changes

3206 21 CFR 820.50(b) Purchasing records, specification

3204 21 CFR 820.40(b) Change records, content

3192 21 CFR 820.30(g) Design validation per user needs and intended use

3141 21 CFR 820.150(a) Storage procedures to prevent mix-ups

2985 21 CFR 812.140(a)(3)(ii) Investigator records of relevant observations

inadequate

2970 21 CFR 812.100 Investigator lack of informed consent

2601 21 CFR 820.30(d) Essential design outputs

3664 21 CFR 820.20(b)(2) Training

3398 21 CFR 820.80(d)(3) No release signature

3379 21 CFR 820.198(e)(5) Nature and details of complaint

3263 21 CFR 820.250(b) Establishment, appropriateness

3232 21 CFR 820.72(a) Equipment suitability & capability

3173 21 CFR 820.198(d) Evaluation, timeliness, identification

3171 21 CFR 820.198(b) Rationale documented for no investigation

3144 21 CFR 820.160(a) Control/distribution procedures

3025 21 CFR 812.150(a)(3) No investigator progress reports

 2980 21 CFR 812.140(a)(1) Investigator correspondence records inadequate

2630 21 CFR 820.30(e) Design review documentation, DHF {see also

820.30(j)}

2599 21 CFR 820.30(d) Acceptance criteria and essential outputs

2470 21 CFR 820.30(c) Design input procedures - appropriateness

631 21 CFR 803.17(a)(1) Lack of System for Event Evaluations

502 21 CFR 820.60 Identification

454 21 CFR 820.40(a) Document review, approval by designated

individual

14508 21 CFR 812.140(a)(4) Investigator record of protocol deviations

inadequate

4208 21 CFR 806.20(a) Records not kept

4193 21 CFR 806.10(b) Time to report - 10 days

3670 21 CFR 820.20(c) Management review participants

3397 21 CFR 820.80(d)(2) Review of data and documentation

3381 21 CFR 820.198(e)(7) Corrective action taken

3266 21 CFR 820.86 Clearly identified

3227 21 CFR 820.70(g)(1) Activity documentation

3191 21 CFR 820.30(g) Design validation production units

2928 21 CFR 812.40 Sponsors' general responsibilities

2649 21 CFR 820.30(f) Design verification acceptance criteria

4192 21 CFR 806.10(a)(2) Report of violation of the Act (see 803.52(e)(9))

3693 21 CFR 820.100(a)(5) Implementing changes

3370 21 CFR 820.198(a)(2) Oral complaints

3306 21 CFR 820.100(a)(7) Management review

3300 21 CFR 820.100(a)(1) Statistical methodology

3190 21 CFR 820.30(g) Design validation acceptance criteria

3149 21 CFR 820.180 Availability

2556 21 CFR 820.30(c) Incomplete, ambiguous, conflicting design

requirements

2430 21 CFR 820.30(b) Adequacy of design and development plan

6847 21 CFR 807.30(b) Listing not updated or update not timely

4169 21 CFR 820.100(a)(7) Identifying relevant info for management review

4168 21 CFR 820.100(a)(7) Management review of CAPA

4060 21 CFR 820.20(b)(3)(i) Management representative implementing the
quality system

3675 21 CFR 820.30(f) Design verification - unresolved discrepancies

3667 21 CFR 820.20(c) Management review accomplishment

3396 21 CFR 820.80(d)(1) DMR required activities {see also 820.181}

3382 21 CFR 820.198(e)(8) Reply to complainant

3330 21 CFR 820.181(d) DMR packaging and labeling specifications

3316 21 CFR 820.160(a) Expired or deteriorated devices

3235 21 CFR 820.72(a) Equipment control activity documentation

3203 21 CFR 820.40(b) Change records maintained

3195 21 CFR 820.30(g) Design validation unresolved discrepancies

3139 21 CFR 820.140 Handling procedures to prevent mix-ups

3111 21 CFR 820.70(f) Buildings

2598 21 CFR 820.30(d) Design output procedures

2339 21 CFR 820.22 Quality audit documentation

733 21 CFR 803.50(b)(1) Reporting Information Reasonably Known

14507 21 CFR 812.140(a)(3)(ii) Investigator adverse effect records inadequate

6800 21 CFR 807.20 Establishment not registered

3694 21 CFR 820.100(a)(6) Dissemination of problem information

3673 21 CFR 820.30(c) Design input approval documentation

3668 21 CFR 820.20(c) Management review dates

3434 21 CFR 820.75(c) Documentation - review in response to changes or

deviations

3425 21 CFR 820.50(a)(1) Evaluation and selection

3313 21 CFR 820.120(d) Records, DHR {see also 820.184(e)}

3312 21 CFR 820.120(d) Mix-ups

3193 21 CFR 820.30(g) Design validation - production units in use

conditions

3161 21 CFR 820.184(a) DHR content - manufacturing dates

3049 21 CFR 812.150(b)(5) Sponsor progress reports for significant risk study

2973 21 CFR 812.110(a) Subject participation prior to study approval

2627 21 CFR 820.30(e) Design reviews performed following schedule

542 21 CFR 820.70(c) Environmental control system periodic inspections

 419 21 CFR 820.20(b) Establish organizational structure

6803 21 CFR 807.20(a) Devices not listed

4071 21 CFR 820.30(i) Design changes - validation vs. verification

4057 21 CFR 820.20(a) Management responsibility

3838 21 CFR 820.40(a) Document review procedures, designated individual

3682 21 CFR 820.70(d) Implementing Personnel Procedures, Health,

Cleanliness.

3671 21 CFR 820.25(a) Personnel education, background, training &

experience

3399 21 CFR 820.80(d)(4) No release authorization date

3349 21 CFR 820.200(d) No documentation

3328 21 CFR 820.180(b) Retention period

3325 21 CFR 820.180 Storage

3007 21 CFR 812.140(d) Record retention inadequate

2969 21 CFR 812.100 No investigator protection - subject rights, safety,

welfare

2431 21 CFR 820.30(b) Design plans updated

2330 21 CFR 820.22 Quality audit corrective action, reaudits {see also
820.100}
 812 21 CFR 803.56 Submission Within One Month

632 21 CFR 803.17(a)(2) Lack of System for Determining MDR Events

14516 21 CFR 812.25(e) Sponsor's lack of written monitoring procedures

7012 21 CFR 812.100 Investigator lack of control of investigational

devices

7006 21 CFR 812.43(c)(5) No financial disclosure info in investigator

agreement

3841 21 CFR 820.90(b)(2) Product rework adverse effects {see also 820.184}

3432 21 CFR 820.75(b)(2) Documentation of validated process performance

3414 21 CFR 820.200(d)(6) Test and inspection data

3376 21 CFR 820.198(e)(2) Date complaint received

3347 21 CFR 820.200(c) Complaints, MDR reports {see also 820.198(a)(3)}

3310 21 CFR 820.120(b) DHR documentation of label release {see also

820.184}

3290 21 CFR 820.90(b)(2) Retesting and reevaluation of reworked product

3218 21 CFR 820.70(c) Environmental control system-

documentation/review inspection

3200 21 CFR 820.40(a) Document locations, dissemination

3168 21 CFR 820.198(a) Designated unit

 3163 21 CFR 820.184(c) Quantity released

3162 21 CFR 820.184(b) Quantity manufactured

3028 21 CFR 812.150(a)(4) No approval for investigator change in non-

emergency

2992 21 CFR 812.140(b)(2) Sponsor device shipment records inadequate

2930 21 CFR 812.42 Sponsor began study before IRB/FDA approval

2602 21 CFR 820.30(d) Design output approval

2481 21 CFR 820.30(c) Design input procedures - addressing conflicting

requirement

2403 21 CFR 820.25(a) Sufficient personnel

2338 21 CFR 820.22 Quality audit/reaudit reports

2276 21 CFR 820.20(b)(1) Responsibility, authority and independence

635 21 CFR 803.17(b)(1) Info evaluated to determine if event was reportable

633 21 CFR 803.17(a)(3) Lack of System for Timely Submission of Reports

14509 21 CFR 812.150(b)(1) Sponsor evaluation report incomplete, inaccurate

7013 21 CFR 812.110(d) Inadequate financial disclosure by investigator

4213 21 CFR 806.20(b)(5) Records of communications

3701 21 CFR 820.250(a) Techniques not used

3674 21 CFR 820.30(d) Design output documentation

3420 21 CFR 820.70(a)(5) Criteria for workmanship

3400 21 CFR 820.80(e)(1) Activities performed

3378 21 CFR 820.198(e)(4) Complainant data

3377 21 CFR 820.198(e)(3) Device identification and control number

3375 21 CFR 820.198(e)(1) Device name

3374 21 CFR 820.198(d)(3) Determination of relationship of device to event

3372 21 CFR 820.198(d)(1) Determination of whether device met specifications

3333 21 CFR 820.184(f) Device identification, control numbers

3309 21 CFR 820.120(b) Examination for accuracy

3241 21 CFR 820.72(b)(1) Calibration standard traceability

3239 21 CFR 820.72(b) Remedial action - documentation

3236 21 CFR 820.72(b) Procedures - content

3224 21 CFR 820.70(g)(2) Periodic equipment inspection

3216 21 CFR 820.70(b) Changes documented

3198 21 CFR 820.40(b) Changes - review and approval

3147 21 CFR 820.170(a) Installation instructions, test procedures

3142 21 CFR 820.150(a) Storage procedures to avoid release of unsuitable

product

3113 21 CFR 820.70(g) Design and installation

3038 21 CFR 812.150(b)(1) Sponsor evaluation rpt not timely, distributed

3034 21 CFR 812.150(a)(6) Investigator final report

3032 21 CFR 812.150(a)(5) Investigator report for lack of informed consent

3027 21 CFR 812.150(a)(4) Investigator non-emergency safety or soundness

changes

3003 21 CFR 812.140(b)(6) Other sponsor records required by FDA inadequate

2993 21 CFR 812.140(b)(2) Sponsor device disposition records inadequate

2991 21 CFR 812.140(b)(1) Sponsor correspondence records inadequate

2975 21 CFR 812.110(c) Investigator did not supervise use of investigational

device

2972 21 CFR 812.110(a) Informed consent obtained prior to study approval

2935 21 CFR 812.43(b) Sponsor shipped devices to unqualified person(s)

 2600 21 CFR 820.30(d) Acceptance criteria not identified

2279 21 CFR 820.20(b)(2) Resources

2270 21 CFR 820.20(a) Implement quality policy

796 21 CFR 803.55(a) Initial Submission of Baseline Report

750 21 CFR 803.52(b)(4) Date of Report by the Initial Reporter

749 21 CFR 803.52(b)(3) Date of Event

735 21 CFR 803.50(b)(2) Explanation of Incomplete Information

14517 21 CFR 812.35(a)(1) No approval for changes requiring prior approval

9176 21 CFR 809.20(b) Compliance with GMP

6849 21 CFR 812.5(a) Label does not contain required information

6805 21 CFR 807.25(b) Device activities not reported

6804 21 CFR 807.21(b) Listing not updated

6802 21 CFR 807.21(a) Annual registration

4436 21 CFR 803.40(a) Report of death, injury by marketed device

4432 21 CFR 803.18(d)(3) Distributor complaint files locations

4207 21 CFR 806.10(d) Notification of extended action

4200 21 CFR 806.10(c)(7) Event description

4167 21 CFR 820.70(g) Specified requirements

4061 21 CFR 820.20(b)(3)(ii) Management representative's reports

3840 21 CFR 820.72(b)(1) In-house calibration standards

3839 21 CFR 820.70(a)(4) Approval of process equipment

3706 21 CFR 820.250(b) Review of sampling methods for adequacy

3698 21 CFR 820.150(b) Procedures - receipt and dispatch

3697 21 CFR 820.150(a) Stock rotation, assessment before release

3691 21 CFR 820.100(a)(4) Verification vs validation

3672 21 CFR 820.30(c) Design input review and approval

3429 21 CFR 820.75(b)(1) Performed by qualified individual

3419 21 CFR 820.70(a)(4) Approval of process

3418 21 CFR 820.70(a)(3) Standards or codes

3404 21 CFR 820.80(e)(5) Equipment

3403 21 CFR 820.80(e)(4) Signature

3385 21 CFR 820.25(b)(1) Training on defects

3373 21 CFR 820.198(d)(2) Determination of use for treatment or diagnosis

3355 21 CFR 820.198(f) Records accessible to manufacturing site

3346 21 CFR 820.200(b) Statistical analysis {see also 820.100(a)(1)}

3343 21 CFR 820.198(e) Maintained

3331 21 CFR 820.181(e) DMR installation/maintenance/servicing procedures

3324 21 CFR 820.170(b) Installer's documentation of results

3311 21 CFR 820.120(c) Storage

3267 21 CFR 820.86 Maintained

3237 21 CFR 820.72(b) Remedial action

3230 21 CFR 820.70(i) Validation of changes to automated process

software

3210 21 CFR 820.65 Documentation of control numbers {see also

820.184}

3202 21 CFR 820.40(b) Changes, communication

3175 21 CFR 820.186 QSR content

3138 21 CFR 820.130 Packaging

3065 21 CFR 812.140(a)(5) Additional investigator records FDA requires

3064 21 CFR 812.140(a)(4) Investigator protocol records inadequate

3057 21 CFR 812.150(b)(8) Sponsor report of use without informed consent

3054 21 CFR 812.150(b)(7) 30-day sponsor notification to FDA

3052 21 CFR 812.150(b)(6) Sponsor notif. of rqst. to return/repair/dispose not

made

3046 21 CFR 812.150(b)(4) No 6-month sponsor reports of current investigators

3002 21 CFR 812.140(b)(5) Sponsor records of adverse device effects &

complaints

2994 21 CFR 812.140(b)(3) Sponsor records of investigator agreements

inadequate

2983 21 CFR 812.140(a)(2)(iii) Investigator records of disposition of devices

inadequate

2942 21 CFR 812.43(c)(4)(iii) No informed consent statement in investigator

agreement

2939 21 CFR 812.43(c)(3) No research termination info in investigator

agreement

2938 21 CFR 812.43(c)(2) No info on relevant experience in investigator

agreement

2937 21 CFR 812.43(c)(1) No curriculum vitae in investigator agreement

2924 21 CFR 812.20(a)(2) Initiation of study prior to FDA IDE approval

2923 21 CFR 812.20(a)(1) Did not submit IDE application to FDA

2916 21 CFR 812.7(d) Investigational device represented as safe and /or

effective

2910 21 CFR 812.7(a) Promotion or test marketing

809 21 CFR 803.55(b)(9) Quantity Manufactured and Distributed

797 21 CFR 803.55(b) Annual Update of Baseline Reports

793 21 CFR 803.53(a) Firm Did Not Submit 5 Day Report

786 21 CFR 803.52(f)(9) Remedial Action Reported per Section 519

785 21 CFR 803.52(f)(8) Use of device not indicated in Block H

784 21 CFR 803.52(f)(7) Remedial Action Taken

781 21 CFR 803.52(f)(4) Date of Device Manufacture

774 21 CFR 803.52(e)(4) Date Received by Manufacturer

766 21 CFR 803.52(d)(1) Name, Address & Phone of Initial Reporter

734 21 CFR 803.50(b)(2) Providing Incomplete or Missing Information

654 21 CFR 803.20(a)(2) Sections G and H not completed by mfr.

642 21 CFR 803.18(b)(1)(i) Adverse events--all info not in file

641 21 CFR 803.18(a) Identification and filing of MDR Files

640 21 CFR 803.18(a) Event files--failure to establish

636 21 CFR 803.17(b)(2) Reports and information documentation

Long Desc

Complaint handling procedures for [receiving] [reviewing] [evaluating] complaints have not been [established] [defined] [documented]
[completed] [implemented]. Specifically, ***

Procedures for corrective and preventive action have not been [adequately] established. Specifically, ***

Corrective and preventive action activities and/or results have not been [adequately] documented. Specifically, ***

Written MDR procedures have not been [developed] [maintained] [implemented]. Specifically, ***

A process whose results cannot be fully verified by subsequent inspection and test has not been [adequately] validated according to
established procedures. Specifically, ***

Management with executive responsibility has not ensured that an adequate and effective quality system has been fully implemented and
maintained at all levels of the organization. Specifically, ***

Procedures for quality audits have not been [adequately] established. Specifically, ***

Procedures for design control have not been established. Specifically,***

Procedures for management review have not been [adequately] established. Specifically,***

Quality [audits][reaudits] have not been performed. Specifically, ***

Document control procedures have not been [established] [maintained]. Specifically,***

The procedures addressing documentation of corrective and preventive action activities were not [established] [defined] [documented]
[complete] [implemented]. Specifically, ***

Complaints involving the possible failure of [a device] [labeling] [packaging] to meet any of its specifications were not [reviewed] [evaluated]
[investigated] where necessary. Specifically, ***

Personnel training is not documented. Specifically, ***

Procedures to ensure equipment is routinely [calibrated] [inspected] [checked] [maintained] have not been [adequately] established.
Specifically, ***

Procedures for design change have not been [adequately] established. Specifically,***

Procedures for finished device acceptance have not been [adequately] established. Specifically, ***

Process validation [activities] [results] have not been [documented] [approved] [adequately documented] [adequately approved].
Specifically, ***

Process control procedures that describe any process controls necessary to ensure conformance to specifications were not [established]
[defined] [documented] [implemented]. Specifically, ***

Appropriate sources of quality data are not adequately analyzed to identify existing and potential causes of nonconforming product and
other quality problems. Specifically, ***

Complaint handling procedures have not been [established] [defined] [documented] [completed] [implemented] to ensure that all complaints
are evaluated to determine whether the complaint should be filed as a Medical Device Report. Specifically, ***

Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been
[adequately] established. Specifically, ***

Procedures have not been [adequately] established to control product that does not conform to specified requirements. Specifically, ***

Not all of the actions needed to correct and prevent the recurrence of nonconforming product and other quality problems have been
identified. Specifically, ***

The device master record does not include or refer to the location of device software specifications. Specifically, ***

Procedures for device history records have not been [adequately] established. Specifically,***

Quality system procedures and instructions have not been established. Specifically,***

Requirements that must be met by [suppliers] [contractors] [consultants] have not been [adequately] established. Specifically, ***

An investigation was not conducted in accordance with [the signed agreement] [the investigational plan] [applicable FDA regulations]
[conditions of approval imposed by an IRB] [conditions of approval imposed by FDA]. Specifically, ***
An investigation was not conducted according to the [signed agreement] [investigational plan] [applicable FDA regulations]. Specifically, ***

An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a
marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
Specifically, ***

Management with executive responsibility has not reviewed the suitability and effectiveness of the quality system [at defined intervals] [with
sufficient frequency]. Specifically, ***

The corrective and preventive procedures addressing the analysis of sources of quality data to identify existing and potential causes of
nonconforming product or other quality problems were not [established] [defined] [documented] [complete] [implemented]. Specifically, ***

Complete complaint files are not maintained. Specifically, ***

Corrective and preventive actions have not been verified or validated to ensure that the action is effective and does not adversely affect the
finished device. Specifically, ***

Risk analysis [was not performed] [is inadequate] [is incomplete]. Specifically, ***

Complaint handling procedures have not been [established] [defined] [documented] [completed] [implemented] to ensure that all complaints
are processed in a uniform and timely manner. Specifically, ***

Procedures for acceptance activities have not been [adequately] established. Specifically,***

Procedures to control environmental conditions have not been [adequately] established. Specifically, ***

No management representative had been appointed to ensure that quality system requirements are met, and to report to management on
the performance of the quality system. Specifically, ***

Procedures for acceptance of incoming product have not been [adequately] established. Specifically, ***

Employees have not been adequately trained. Specifically, ***

Procedures for training and identifying training needs have not been [adequately] established. Specifically, ***

An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a
marketed device may have caused or contributed to a death or serious injury. Specifically, ***
Records of each subject's [case history] [exposure to the investigational device] are not all [accurate] [complete] [current]. Specifically, ***

Quality audits were not performed [at defined intervals] [at sufficient frequency] to determine whether the quality system activities and results
comply with quality system procedures. Specifically, ***

Acceptance activities were not [documented] [maintained as part of the device history record] [adequately documented] [adequately
maintained as part of the device history record]. Specifically, ***

There is [no] [incomplete] documentation of the [disposition of nonconforming product] [justification for use of nonconforming product] [the
signature of the individual authorizing the use of nonconforming product]. Specifically, ***

The device history record does not include [complete] acceptance records that demonstrate the device is manufactured in accordance with
the device master record. Specifically, ***

Procedures for addressing the [identification] [documentation] [evaluation] [segregation] [disposition] [investigation] of nonconforming
product were not [defined] [documented] [complete]. Specifically, ***

Software used as part of [production] [the quality system] has not been [adequately] validated for its intended use according to an
established protocol. Specifically, ***

A validated process was not [reviewed and evaluated] [revalidated] when changes or process deviations occurred. Specifically, ***

The [evaluation] [investigation] of nonconforming product has not been documented. Specifically, ***

Documents that were [not approved] [obsolete] were observed at a location where they [could be] [are being] used. Specifically, ***

The documentation of approval of documents does not include [the document approval date] [the signature of the approving official].
Specifically, ***

A quality plan has not been [adequately] established. Specifically, ***

Not all [data] [reports] from quality data sources are analyzed to identify existing and potential causes of nonconforming product and other
quality problems. Specifically, ***

The corrective and preventive action procedures addressing the investigation of the cause of nonconformities relating to product, processes,
and the quality system were not [established] [defined] [documented] [complete] [implemented]. Specifically, ***

Process controls are not conducted in accordance with documented instructions and standard operating procedures. Specifically, ***
The device history record does not include the primary identification label and labeling for each device. Specifically, ***

The device history record does not demonstrate that the device was manufactured in accordance with [the device master record] [21 CFR
820].

The design history file [was not established] [does not demonstrate that the design was developed following the approved design plan] [does
not demonstrate that the design was developed following the requirements of 21 CFR 820].

Production processes were not [developed] [conducted] [controlled] [monitored] to ensure that a device conforms to its specifications.
Specifically, ***

Procedures for design validation have not been [adequately] established. Specifically,***

Individuals who conduct quality audits have direct responsibility for the matters being audited. Specifically, ***

A correction or removal, conducted to reduce a risk to health posed by a device, was not reported in writing to FDA. Specifically, ***

Certain indicators of nonconformities are not investigated to determine the cause of the nonconformity. Specifically, ***

Records of complaint investigations do not include the [dates] [results] of the investigation. Specifically, ***

There is [no] [incomplete] documentation of [the equipment identification] [calibration dates] [the individual performing each calibration] [the
next calibration date] for [inspection] [measurement] [test] equipment . Specifically, ***

Procedures for monitoring and control of process parameters for a validated process have not been [adequately] established. Specifically,
***

Incoming product was not adequately inspected or tested to verify conformance to specifications. Specifically, ***

Products that do not conform to specifications are not adequately controlled. Specifically, ***

Procedures were not [established] [defined] [documented] [complete] [implemented] for ensuring that participants at each design review
include [representatives of all functions concerned with the design stage being reviewed] [an individual who does not have direct
responsibility for the design stage being reviewed] [any specialists needed]. Specifically, ***

The [quality policy] [quality objectives] [was] [were] not established by management with executive responsibility. Specifically, ***
The results of design validation, including [identification of the design] [method(s)] [the date] [the individual(s) performing validation], were
not [adequately] documented in the design history file. Specifically, ***

Validation of device software [was not performed] [is inadequate] [is incomplete]. Specifically, ***

Changes in methods and procedures needed to correct and prevent identified quality problems are not [implemented] [recorded] [effective].
Specifically, ***

Procedures for design transfer have not been [adequately] established. Specifically,***

Schedules for the adjustment, cleaning, and other maintenance of equipment have not been [adequately] established. Specifically, ***

Records of [receipt] [use] [disposal] of a device that relate to the [type and quantity] [dates of receipt] [batch number or code mark] of the
device are not all [accurate] [complete] [current]. Specifically, ***

Procedures for design verification have not been [adequately] established. Specifically,***

Procedures for verifying that design output meets design input were not [established] [defined] [documented] [complete] [implemented].
Specifically, ***

A design and development plan has not been [established] [defined] [documented] [implemented]. Specifically, ***

The procedures addressing verification or validation of corrective and preventive actions were not [established] [defined] [documented]
[complete] [implemented]. Specifically, ***

Procedures for rework of nonconforming product have not been [adequately] established. Specifically, ***

The device master record does not include or refer to the location of [all] quality assurance procedures and specifications. Specifically, ***

Procedures to control labeling activities have not been [adequately] established. Specifically, ***

Process control procedures that describe any process controls necessary to ensure conformance to specifications have not been
[adequately] established. Specifically, ***

The type and extent of control to be exercised over [the product] [services] [suppliers] [contractors] [consultants] was not clearly defined.
Specifically, ***
Procedures or instructions for [performing servicing activities] [verifying that servicing meets specified requirements] have not been
[adequately] established. Specifically, ***

Procedures that define the responsibility for review and the authority for the disposition of nonconforming product have not been
[adequately] established. Specifically, ***

The device master record does not include or refer to the location of [all] production and process specifications. Specifically, ***

Records documenting that informed consent was obtained for each subject prior to participation in the study are not all [accurate] [complete]
[current]. Specifically, ***

A justification for not reporting the correction or removal action to FDA that included [conclusions] [follow-ups] [reviews] by a designated
person was not included in the record. Specifically,***

The procedures addressing identification of corrective and preventive actions were not [established] [defined] [documented] [complete]
[implemented]. Specifically, ***

Software validation activities and results for computers or automated data processing systems used as part of [production] [the quality
system] have not been [adequately] documented. Specifically, ***

Procedures for the [acceptance] [control] of in-process product have not been [adequately] established. Specifically, ***

Procedures for changes to a [specification] [method] [process] [procedure] have not been [adequately] established. Specifically, ***

Changes to a [specification] [method] [process] [procedure] were not verified or validated. Specifically, ***

During production, [process parameters] [component and device characteristics] are not [fully] monitored and controlled. Specifically, ***

Acceptance records were not maintained as part of the device history record. Specifically, ***

In-process inspections, tests, or other verification activities and approvals were not documented. Specifically, ***

Required records are not legible. Specifically, ***

A complete and accurate report of an unanticipated adverse device effect was not prepared and submitted [within 10 working days after first
learning of the effect] to [the sponsor] [the reviewing IRB]. Specifically, ***
Procedures for design review have not been [adequately] established. Specifically,***

Established procedures were not followed [completely] in making changes to [specifications] [methods] [processes] [procedures].
Specifically, ***

Rework and reevaluation activities have not been [fully] documented in the device history record. Specifically, ***

The [appropriate design, construction, placement, and installation of manufacturing equipment have not been ensured] [equipment used in
the manufacturing process does not meet specified requirements]. Specifically, ***

The evaluation of potential [suppliers] [contractors] [consultants] was not documented. Specifically, ***

Acceptance or rejection of incoming product was not documented. Specifically, ***

Not all complaints have been [adequately] reviewed and evaluated to determine whether an investigation is necessary. Specifically, ***

Procedures to prevent contamination of equipment or product by substances that may have an adverse effect on product quality have not
been [adequately] established. Specifically, ***

Design input requirements were not [adequately] documented. Specifically, ***

There is no information to support the appropriateness of the statistical techniques used. Specifically, ***

The design verification results, including [identification of the design] [method(s)] [the date] [the individual(s) performing the verification],
were not [adequately] documented in the design history file. Specifically, ***

Records of acceptable [suppliers] [contractors] [consultants] were not maintained. Specifically, ***

Procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process
capability and product characteristics have not been [adequately] established. Specifically,***

There is no agreement with [suppliers] [contractors] [consultants] to notify you of changes in the product or service. Specifically, ***

Purchasing data that clearly describe or reference specified requirements for purchased or otherwise received product and services have
not been [approved] [established] [adequately approved] [adequately established]. Specifically, ***
Records of changes did not include [a description of the change] [identification of the affected documents] [the signature of the approving
official(s)] [the approval date] [when the change became effective]. Specifically, ***

Design validation did not ensure the device conforms to defined user needs and intended uses. Specifically, ***

Procedures for controlling the storage of product in storage areas and stock rooms were not [established] [defined] [documented] [complete]
[implemented] to prevent mix-ups, damage, other adverse effects. Specifically, ***

Records for each subject concerning [previous medical history] [condition upon entering the investigation] [condition during the course of the
investigation] [all diagnostic test results] are not all [accurate] [complete] [current]. Specifically, ***

Informed consent was not obtained in accordance with the regulations regarding the protection of human subjects. Specifically, ***

Design outputs that are essential for the proper functioning of the device were not [completely] identified. Specifically, ***

Personnel are not adequately trained to perform [management activities] [work] [assessment activities] [audits]. Specifically, ***

Finished devices were released for distribution without signature of the individual designated to authorize such release. Specifically, ***

Records of complaint investigations do not include the nature and details of the complaint. Specifically, ***

Sampling plans are not [written][based on valid statistical rationale]. Specifically, ***

Certain [inspection] [measuring] [test] equipment is not [suitable for its intended purposes] [capable of producing valid results]. Specifically,
***

Complaints representing events that are MDR reportable were not [promptly reviewed, evaluated, and investigated by a designated
individual] [maintained in a separate portion of the complaint files] [clearly identified]. Specifically, ***

Records for complaints where no investigation was made do not include required information. Specifically ***

Procedures for the control and distribution of finished devices have not been [established] [defined] [documented] [complete] [implemented]
to ensure that only devices approved for release are distributed. Specifically, ***

Progress reports on the investigation were not submitted [at the required intervals] [at least yearly] to the [sponsor] [monitor] [reviewing IRB].
Specifically, ***
Records relating to correspondence with [another investigator] [an IRB] [the sponsor] [a monitor] [FDA], including required reports, are not
all [accurate] [complete] [current]. Specifically, ***

The design review results, including [identification of the design] [the date] [the individual(s) performing the review], were not documented in
the design history file. Specifically, ***

Design output procedures do not [contain or reference acceptance criteria] [ensure that essential design outputs are identified] [allow for an
adequate evaluation of conformance to design input requirements]. Specifically, ***

Procedures to ensure that a device's design input requirements are appropriate and address its intended use, including user/patient needs,
were not [established] [defined] [documented] [complete] [implemented]. Specifically, ***

The written MDR Procedure does not include an internal system which provides for the timely and effective [identification] [communication]
[evaluation] of events that may be subject to medical device reporting requirements. Specifically, ***

Procedures for identifying product during all stages of receipt, production, distribution, and installation have not been [adequately]
established. Specifically, ***

Documents were [not reviewed] [not approved] by designated individual(s) prior to issuance . Specifically, ***

Records showing [dates] [reasons for] each deviation from the protocol are not all [accurate] [complete] [current]. Specifically,***

There is no record maintained of a correction or removal action that was not required to be reported to FDA. Specifically,***

A report of the required information regarding device correction and removal actions was not sent to FDA within 10 days of initiating the
correction or removal. Specifically, ***

Documentation does not show that management with executive responsibility participated in management reviews. Specifically, ***

Finished devices were released for distribution before the associated data and documentation was reviewed. Specifically, ***

Records of complaint investigations do not include any corrective action taken. Specifically, ***

The acceptance status of product was not [identified to indicate conformance or nonconformance with acceptance criteria] [maintained].
Specifically, ***

Maintenance activities, including the [date] [individuals performing those activities], have not been documented. Specifically, ***
The design was not validated [under defined operating conditions] [using initial production units, lots or batches or their equivalents].
Specifically, ***

For an investigational study, [qualified investigators were not selected] [investigators were not provided with the information they need to
conduct an investigation properly] [proper monitoring was not ensured] [IRB review and approval were not ensured] [an IDE application was
not submitted to FDA for a significant risk study] [reviewing IRBs were not promptly informed of significant new information about an
investigation] [FDA was not promptly informed of significant new information about an investigation]. Specifically, ***

Acceptance criteria were not [established] [defined] [documented] [complete] [implemented] prior to the performance of verification activities.
Specifically, ***

A violation of the FD&C Act involving a device which might present a risk to health was not reported to FDA. Specifically, ***

Corrective and preventive action procedures addressing implementation and recording of changes in methods and procedures to correct
and prevent identified quality problems were not [established] [defined] [documented] [complete] [implemented]. Specifically, ***

Complaint handling procedures have not been [established] [defined] [documented] [completed] [implemented] to ensure that all oral
complaints are documented upon receipt. Specifically, ***

The procedures addressing submission of information on identified quality problems and corrective and preventive actions for management
review were not [established] [defined] [documented] [complete] [implemented]. Specifically, ***

Corrective and preventive action procedures addressing the use of appropriate statistical methodology to identify existing and potential
causes of nonconforming product or other quality problems were not [established] [defined] [documented] [complete] [implemented].
Specifically, ***

Acceptance criteria were not established prior to the performance of validation activities. Specifically, ***

Required records [are not maintained at a location that is reasonably accessible to responsible officials of the manufacturer and to
employees of the FDA] [were not made readily available for review and copying by the FDA] [are not legible] [are not stored to minimize
deterioration and prevent loss] [are not backed up when stored in automated data processing systems]. Specifically, ***

Design input requirements that are [incomplete] [ambiguous] [conflicting] were not addressed. Specifically, ***

Design plans that describe or reference the design and development activities and define responsibility for implementation have not been
[adequately] established. Specifically, ***

Device listing information was not updated [in a timely manner]. Specifically, ***

Procedures addressing identification of relevant information to be submitted for management review were not [established] [defined]
[documented] [complete] [implemented]. Specifically, ***

Information on identified quality problems and corrective actions has not been [submitted for review by] [reviewed by] management.
Specifically, ***
The management representative has not ensured that the quality system requirements are effectively established and maintained.
Specifically, ***

Unresolved discrepancies were noted at the completion of the design verification. Specifically, ***

Management reviews do not ensure that the quality system satisfies [the requirements of part 820] [your quality policy and objectives].
Specifically, ***

Finished devices were released for distribution prior to completion of activities required in the Device Master Record. Specifically, ***

Records of complaint investigations do not include any reply to the complainant. Specifically, ***

The device master record does not include or refer to the location of [packaging] [labeling] procedures and specifications. Specifically, ***

Procedures have not been [established] [defined] [documented] [complete] [implemented] to ensure that expired or deteriorated devices are
not distributed. Specifically, ***

Equipment [calibrations] [inspections] [checks][maintenance activities] have not been documented. Specifically, ***

Records of changes to documents were not [adequately] maintained. Specifically, ***

Unresolved discrepancies were noted at the completion of the design validation. Specifically, ***

Procedures for product handling have not been [adequately] established. Specifically,***

Buildings [are not of suitable design] [do not contain sufficient space] to [perform necessary operations] [prevent mix-ups] [assure orderly
handling of product]. Specifically, ***

Procedures for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input
requirements were not [established] [defined] [documented] [complete] [implemented]. Specifically, ***

The dates of quality [audits][reaudits] have not been documented. Specifically, ***

An MDR report submitted to FDA did not include all information that was reasonably known to the manufacturer. Specifically, ***
Records for each subject concerning [anticipated] [unanticipated] adverse device effects are not all [accurate] [complete] [current].
Specifically, ***

An establishment for which registration is required has not been registered. Specifically, ***

Information related to quality problems or nonconforming product is not disseminated to those directly responsible for assuring the [quality of
the product] [prevention of the quality problem]. Specifically, ***

The approval of design input requirements [(including the date and signature of the individual approving the requirements)] was not
documented. Specifically, ***

The results and/or dates of management reviews are not documented. Specifically, ***

There is no documentation of the [review and evaluation of a process] [revalidation of a process] performed in response to changes or
process deviations. Specifically, ***

Potential [suppliers] [contractors] [consultants] were not [evaluated] [selected] based on their ability to meet specified requirements.
Specifically, ***

Labels and labeling used for each finished product, lot, or batch, were not sufficiently documented in the DHR. Specifically, ***

Labeling and packaging operations were not controlled to prevent labeling mix-ups. Specifically, ***

The design was not validated under actual or simulated use conditions. Specifically, ***

The device history record does not include manufacturing dates. Specifically, ***

Progress reports for a significant risk device study were not submitted [at required intervals] [at least yearly] to [FDA] [all reviewing IRBs].
Specifically, ***

Subjects were allowed to participate in an investigation prior to obtaining [IRB] [FDA] approval to conduct the investigation. Specifically, ***

Design reviews were not performed at appropriate times, following the review schedule. Specifically, ***

Environmental control systems have not been inspected periodically to verify that the system, including necessary equipment, is adequate
and functioning properly. Specifically, ***
The organizational structure has not been [adequately] established and maintained to ensure that devices are [designed] [produced] in
accordance with 21 CFR 820. Specifically, ***

Devices for which listing is required have not been listed. Specifically, ***

Procedures were not [established] [defined] [documented] [completed] to address when verification of design changes is sufficient in lieu of
validation prior to their implementation. Specifically, ***

Management with executive responsibility has not ensured that the quality policy is understood, implemented and maintained at all levels of
the organization. Specifically, ***

The document control procedures do not designate an individual to review documents for adequacy and approve them prior to issuance.
Specifically, ***

Requirements addressing the [health] [cleanliness] [personal practices] [clothing] of employees have not been implemented. Specifically, ***

Personnel do not have the necessary [education] [background] [training] [experience] to perform their jobs. Specifically, ***

Finished devices were released for distribution without the authorization being dated. Specifically, ***

Service reports were not documented. Specifically, ***

Required records are not retained for [the design and expected life of the device] [at least 2 years from the date of release of the device for
commercial distribution]. Specifically, ***

Required records [are not stored so as to minimize deterioration and prevent loss] [that are stored in automated data processing systems
are not backed up]. Specifically, ***

Required records were not all maintained [during the investigation] [for a period of two years after the date on which an investigation was
terminated or completed] [for a period of two years after the date that the records were no longer required for purposes of supporting a
premarket approval application or a notice of completion of a product development protocol]. Specifically, ***

The rights, safety, and welfare of subjects in an investigational study were not [adequately] protected. Specifically, ***

Design plans were not [reviewed] [updated] [approved] as design and development evolves. Specifically, ***

Quality reaudits [are not adequately performed] [do not cover corrective actions for the problem areas]. Specifically, ***
A supplemental report was not submitted to FDA within one month following receipt of information that was not provided when the initial
report was submitted. Specifically, ***

The written MDR procedure does not include an internal system which provides for a standardized review process/procedure for
determining when an event meets the criteria for reporting. Specifically, ***

There are no written procedures for monitoring an investigational device study. Specifically,***

Devices under investigation were not properly controlled. Specifically, ***

A signed agreement was not obtained from each participating investigator that includes [sufficient accurate financial disclosure information
to allow the sponsor to submit a complete and accurate certification or disclosure statement] [a commitment to promptly update financial
disclosure information if any relevant changes occur during the investigation and for one year following completion of the study].
Specifically, ***

Documentation of rework and reevaluation activities does not include a determination of whether there has been any adverse effect from
rework upon the product. Specifically, ***

There is [no] [inadequate] documentation of [monitoring and control methods and data] [the date performed] [the individual performing the
process] [the major equipment used] for a validated process. Specifically, ***

Service reports do not include applicable test and/or inspection data. Specifically, ***

Records of complaint investigations do not include the date the complaint was received. Specifically, ***

Service reports that represent MDR reportable events were not automatically considered complaints and processed in accordance with the
requirements of 21 CFR 820.198. Specifically, ***

The DHR does not include [complete] records of examination and release of device labeling, including date and signature of the examiner.
Specifically, ***

Rework of nonconforming product did not include [complete] retesting and reevaluation to ensure that the reworked product met current
approved specifications. Specifically, ***

Inspections of environmental control system were not [documented] [reviewed]. Specifically, ***

Documents were not available at all locations for which they are designated, used, or otherwise necessary. Specifically, ***

Complaint files are not [adequately] maintained. Specifically ***

The device history record does not include the quantity of devices released for distribution. Specifically, ***

The device history record does not include the quantity of devices manufactured. Specifically, ***

Prior approval was not obtained from the sponsor for [changes in] [deviations from] an investigational plan in a non-emergency situation.
Specifically, ***

Records of shipment of an investigational device that include the [name and address of the consignee] [type and quantity of device] [date of
shipment] [batch number or code mark] reports are not all [accurate] [complete] [current]. Specifically, ***

[An investigation] [Part of an investigation] was initiated before [FDA approval] [IRB approval]. Specifically, ***

Design output was not [reviewed] [approved] before release. Specifically, ***

Procedures for addressing incomplete, ambiguous, or conflicting design input requirements were not [established] [defined] [documented]
[complete] [implemented]. Specifically, ***

Insufficient personnel to assure that all procedures are appropriately carried out as required by the quality system. Specifically, ***

Reports of results of quality [audits] [reaudits] are not reviewed by management having responsibility for the matters audited. Specifically,
***

Employees who manage, perform, and assess work affecting quality have not been [assigned the appropriate responsibility and authority]
[provided the independence and authority] to accomplish their work. Specifically, ****

The written MDR procedure does not include documentation and recordkeeping requirements for all information that was evaluated to
determine if an event was reportable. Specifically, ***

The written MDR procedure does not include an internal system which provides for timely transmission of complete medical device reports
to [FDA] [manufacturers]. Specifically, ***

Reports of the results of evaluation of unanticipated adverse device effects were not all [complete] [accurate]. Specifically, ***

The sponsor was not supplied [sufficient financial information to allow submission of complete and accurate certification or disclosure
statements] [financial disclosure updates when a relevant change occurred during the course of the study or within one year following study
completion]. Specifically, ***

A copy of all communications regarding the correction or removal action was not contained in the record. Specifically,***
Statistical techniques are not used for control purposes where statistical techniques are applicable. Specifically, ***

Design output was not [adequately] documented before release. Specifically, ***

Criteria for workmanship have not been expressed in documented standards or by means of identified and approved representative
samples. Specifically, ***

Acceptance records did not include the acceptance activities performed. Specifically, ***

Records of complaint investigations do not include the [name] [address] [phone number] of the complainant. Specifically, ***

Records of complaint investigations do not include device identifications and control numbers used. Specifically, ***

Records of complaint investigations do not include required information. Specifically, ***

Investigation of MDR reportable complaints did not include a determination of the relationship of the device to the reported incident or
adverse event. Specifically, ***

Investigation records of MDR reportable complaints do not include required information. Specifically ***

The device history record does not include [certain] [any] device identifications and control numbers used. Specifically, ***

Labeling was not sufficiently examined by a designated individual for accuracy including [the correct expiration date] [control numbers]
[storage instructions] [handling instructions] [certain additional processing instructions] before release. Specifically, ***

A calibration standard used for [inspection] [measurement] [test] equipment is not traceable to national or international standards nor is it an
independent reproducible standard. Specifically, ***

Evaluations of out-of-calibration equipment and remedial actions taken were not documented. Specifically, ***

Calibration procedures do not include [specific directions and limits for accuracy and precision] [provisions for remedial action]. Specifically,
***

Procedures for conducting periodic inspections to ensure adherence to equipment maintenance schedules have not been [adequately]
established. Specifically, ***
Changes were not [documented] [followed]. Specifically, ***

Changes to documents were not [reviewed and approved by an individual(s) in the same function or organization that performed the original
review and approval] [communicated to appropriate personnel in a timely manner]. Specifically, ***

[Installation instructions] [inspection instructions] [test procedures] have not been [adequately] established. Specifically,***

Procedures for controlling the storage of product in storage areas and stock rooms are not adequate to ensure that no obsolete, rejected, or
deteriorated product is distributed. Specifically, ***

Equipment used in the manufacturing process has not been appropriately [designed] [constructed] [placed] [installed] to facilitate
maintenance, adjustment, cleaning, and use. Specifically, ***

Reports of the results of evaluation of unanticipated adverse device effects were not all submitted [within 10 working days of receiving notice
of the effect] to [FDA] [all reviewing IRBs] [all participating investigators]. Specifically, ***

A final report to the [sponsor] [reviewing IRB] was not submitted [within three months] after [termination] [completion] of the investigation.
Specifically, ***

A report to the [sponsor] [reviewing IRB] regarding the use of an investigational device without obtaining informed consent was not
submitted [within five working days after the use occurred]. Specifically, ***

In a non-emergency situation, [changes to] [deviations from] the investigational plan that could have affected [the scientific soundness of the
plan] [the rights, safety, or welfare of human subjects] were initiated without prior approval of the changes from [the sponsor] [FDA] [the
IRB] . Specifically, ***

Records that FDA requires to be maintained for [a category of investigation] [a particular investigation] are not all [accurate] [complete]
[current]. Specifically, ***

Records of disposition of a device which describe the batch number or code marks of any devices [returned to the sponsor] [repaired]
[disposed of by the investigator or another person] and the reasons for and method of disposition reports are not all [accurate] [complete]
[current]. Specifically, ***

Records relating to correspondence with [another sponsor] [a monitor] [an investigator] [an IRB] [FDA], including required reports are not all
[accurate] [complete] [current]. Specifically, ***

An investigational device was used for subjects not under the supervision of an authorized investigator. Specifically, ***

Written informed consent of potential subjects to participate in an investigation was obtained prior to obtaining [IRB] [FDA] approval to
conduct the investigation. Specifically, ***

Investigational devices were shipped to individuals who were not qualified investigators participating in the investigation. Specifically, ***
Acceptance criteria for design outputs were not identified. Specifically, ***

Adequate resources have not been provided for performing [management activities] [work] [assessment activities] [audits]. Specifically, ***

Not all employees [know there is] [understand] [fully implement] the quality policy. Specifically, ***

A baseline report on FDA Form 3417 or approved electronic equivalent was not submitted following the first MDR report on a device model.
Specifically, ***

An individual medical device manufacturer report submitted per FDA Form 3500A did not contain in Block B the date of report by the initial
reporter. Specifically, ***

An individual medical device manufacturer report submitted per FDA Form 3500A did not contain in Block B the date of the event.
Specifically, ***

An MDR report with incomplete information was submitted to FDA without a statement explaining why such information was incomplete and
the steps taken to obtain the information. Specifically, ***

[FDA] [IRB] approval was not obtained for changes to an investigational plan that require prior approval. Specifically, ***

In vitro diagnostic products are not being manufactured in accordance with the good manufacturing practices set forth in the Quality System
Regulation. Specifically, ***

The label for an investigational device does not include [the name and place of business of manufacturer, packer, or distributor] [the quantity
of contents] [the statement "CAUTION -- Investigational device. Limited by Federal (or United States) law to investigational use."].
Specifically, ***

Device activities have not been reported to FDA. Specifically, ***

Existing device information changed, but the listing was not updated during [June] [December] (or earlier) as required. Specifically, ***

Your annual registration [is not current] [was not updated within 30 days of receipt of form FDA 2891a from FDA]. Specifically, ***

The importer failed to submit a report to FDA on FDA form 3500A, with a copy to the manufacturer, within 30 days after receiving
information that one of its marketed devices may have caused or contributed to a [death] [serious injury]. Specifically, ***

The device distributor does not maintain the device complaint files at the distributor's principal business establishment. Specifically, ***
No amended notification with required information was submitted within 10 working days of initiating an extension of the correction or
removal action. Specifically,***

The events that led to reporting and/or conducting the correction or removal actions were not described. Specifically,***

Equipment used in the manufacturing process does not meet specified requirements. Specifically, ***

The management representative has not [fully] reported on the quality system performance to management with executive responsibility.
Specifically, ***

In the absence of a national or international standard, or an independent reproducible standard, no in-house standard has been established
for [inspection] [measuring] [test] equipment. Specifically, ***

Process equipment has not been approved. Specifically, ***

The review of sampling methods for adequacy for their intended use was not documented. Specifically, ***

Procedures were not established for authorizing receipt from and dispatch to storage areas and stock rooms. Specifically, ***

Product was not stored to facilitate proper stock rotation and to assess its condition as appropriate. Specifically, ***

There is no corrective and preventive action procedure to determine when verification can be conducted in lieu of validation. Specifically, ***

Design input requirements were not [reviewed] [approved] by designated individual(s). Specifically, ***

A validated process was not performed by a qualified individual. Specifically, ***

Processes have not been approved. Specifically, ***

Process controls do not include testing devices for compliance with applicable standards or codes, as required by device specifications.
Specifically, ***

Acceptance records did not identify the equipment used in the tests. Specifically, ***
Acceptance records did not include the signature of the individual performing the acceptance activities. Specifically, ***

Employees have not been made aware of device defects that could occur when they improperly perform their jobs. Specifically, ***

Investigation of MDR reportable complaints did not include a determination of whether the device was being used for treatment or diagnosis.
Specifically, ***

Investigated complaints and records of investigation were not accessible to the manufacturing establishment. Specifically, ***

Service reports were not analyzed following appropriate statistical methods. Specifically, ***

Records of complaint investigations are not maintained by the formally designated unit. Specifically, ***

A device master record has not been [adequately] maintained. Specifically, ***

The person installing the device did not document complete inspection and test results to demonstrate proper installation. Specifically, ***

Labels were stored such that mix-ups were possible. Specifically, ***

The acceptance status of product was not clearly identified throughout [manufacturing] [packaging] [labeling] [installation] [servicing] of the
product. Specifically, ***

When test/measurement equipment was found to not meet accuracy and precision limits, [no] [inadequate] action was taken to [bring the
equipment into calibration] [evaluate whether there was any adverse effect on the device's quality]. Specifically, ***

Changes to software used as part of [production] [the quality system] were not [adequately] validated before approval and issuance.
Specifically, ***

Control numbers for [implantable or life supporting devices] [appropriate components] were not documented in the device history record.
Specifically, ***

Approved changes were not communicated to appropriate personnel in a timely manner. Specifically, ***

The quality system record has not been [adequately] maintained Specifically ***
Device packaging and/or shipping containers are not designed and constructed to protect the device from alteration or damage during
processing, storage, handling, and distribution. Specifically, ***

Records that FDA requires by [regulation] [specific requirement] to be maintained for [a category of investigations] [a particular investigation]
are not all [accurate] [complete] [current]. Specifically, ***

Copies maintained of the study protocol are not all [accurate] [complete] [current]. Specifically, ***

A copy of a report from an investigator regarding use of an investigational device without obtaining informed consent was not submitted to
FDA [within five working days of receipt]. Specifically, ***

FDA was not notified [within 30 working days] of the [completion] [termination] of a significant risk device study. Specifically, ***

Notification was not sent to [FDA] [all reviewing IRBs] of a request that an investigator [return] [repair] [dispose of] any units of a device.
Specifically, ***

Current lists of the names and addresses of all investigators participating in an investigation were not [always] submitted to FDA at six month
intervals after FDA approval of the investigation. Specifically, ***

Records concerning [anticipated adverse device effects] [unanticipated adverse device effects] [complaint] reports are not all [accurate]
[complete] [current]. Specifically, ***

Signed investigator agreements that include the required financial disclosure information are not all [accurate] [complete] [current].
Specifically, ***

Records that relate to the [reason why devices] [quantity of devices that] were [returned to the sponsor] [repaired] [disposed of] are not all
[accurate] [complete] [current]. Specifically, ***

A signed agreement that includes a statement of the investigator's commitment to ensure that the requirements for obtaining informed
consent are met was not obtained from each participating investigator. Specifically, ***

A signed agreement, that includes an explanation of the circumstances that led to the termination of any investigations in which the
investigator was involved, was not obtained from each participating investigator. Specifically, ***

A signed agreement that includes the specifics of the investigator's relevant experience was not obtained from each participating
investigator. Specifically, ***

The signed investigator agreements obtained from each participating investigator do not all include the investigator's curriculum vitae.
Specifically, ***

FDA approval was not obtained prior to initiation of an investigation for which an FDA-approved IDE was required. Specifically, ***
An application was not submitted to FDA when [a significant risk device investigation was to be undertaken] [an investigation that involves
exception from informed consent was intended] [FDA sent notification that an application was required for an investigation]. Specifically, ***

An investigational device was represented as being [safe] [effective] for the purposes for which it [is] [was] being investigated. Specifically,
***

An investigational device was [promoted] [test marketed] prior to FDA approval/clearance. Specifically, ***

A baseline report submitted on FDA Form 3417 did not contain [the number of devices manufactured and distributed in the last 12 months]
[an estimate of the number of devices in current use]. Specifically, ***

A baseline report was not updated annually, on the anniversary month of the initial submission, after the initial baseline report was
submitted. Specifically, ***

A 5 day report was not submitted to FDA on Form 3500A within 5 workdays of becoming aware that a reportable MDR event necessitates
remedial action to prevent an unreasonable risk of substantial harm to the public health. Specifically, ***

An individual medical device manufacturer report submitted per FDA Form 3500A did not indicate in Block H whether remedial action was
reported as a removal or correction under Section 519(f) of the FD&C Act, and listing the correction/removal report number. Specifically, ***

An individual medical device manufacturer report submitted per FDA Form 3500A did not indicate in Block H whether use of the device was
initial, reuse, or unknown. Specifically, ***

An individual medical device manufacturer report submitted per FDA Form 3500A did not indicate in Block H whether remedial action was
taken and type. Specifically, ***

An individual medical device manufacturer report submitted per FDA Form 3500A did not indicate in Block H the date of device manufacture.
Specifically, ***

An individual medical device manufacturer report submitted per FDA Form 3500A did not indicate in Block G the date received by the
manufacturer. Specifically, ***

An individual medical device manufacturer report submitted per FDA Form 3500A did not contain in Block E the [name] [address] [phone
number] of the reporter who initially provided information. Specifically, ***

The firm did not obtain and provide FDA with information that is incomplete or missing from reports submitted by user facilities, distributors,
and other initial reporters. Specifically, ***

The device manufacturer did not complete Sections G and H on the back side of FDA Form 3500A. Specifically, ***

MDR event files do not contain or reference all adverse event information in the possession of the reporting entity, including documentation
of the deliberations and decision making process used to determine if an event was or was not reportable. Specifically, ***
MDR event files have not been [prominently identified as such] [filed to facilitate timely access]. Specifically, ***

MDR event files have not been established and maintained. Specifically, ***

The written MDR procedure does not include documentation and recordkeeping requirements for all Medical Device Reports and
information submitted to [FDA] [device manufacturers]. Specifically, ***
Frqncy

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Center Name Cite Id Ref No Short Desc

Drugs 1105 21 CFR 211.22(d) Procedures not in writing, fully followed

3585 21 CFR 211.110(a) Control procedures to monitor and validate

performance

2027 21 CFR 211.192 Investigations of discrepancies, failures

3603 21 CFR 211.160(b) Scientifically sound laboratory controls

1361 21 CFR 211.100(a) Absence of Written Procedures

1358 21 CFR 211.100(b) SOPs not followed / documented

1883 21 CFR 211.165(a) Testing and release for distribution

2009 21 CFR 211.188 Prepared for each batch, include complete

information

1112 21 CFR 211.25(a) Training--operations, GMPs, written procedures

1215 21 CFR 211.67(b) Written procedures not established/followed

2419 21 CFR 211.198(a) Complaint Handling Procedure

1213 21 CFR 211.67(a) Cleaning / Sanitizing / Maintenance

4314 21 CFR 211.84(d)(2) Reports of Analysis (Components)

1943 21 CFR 211.180(e)(1) Review of representative number of batches

4576 21 CFR 211.192 No written record of investigation

1274 21 CFR 211.68(a) Calibration/Inspection/Checking not done

2026 21 CFR 211.192 Quality control unit review of records

1890 21 CFR 211.165(e) Test methods

1177 21 CFR 211.63 Equipment Design, Size and Location

1914 21 CFR 211.166(a) Lack of written stability program

4389 21 CFR 211.198(a) Procedures to be written and followed

4391 21 CFR 211.180(e)(2) Items to cover on annual reviews

1133 21 CFR 211.25(a) GMP Training Frequency

4352 21 CFR 211.160(b)(4) Calibration - at intervals, written program,

remedial action

4372 21 CFR 211.188(b)(8) Labeling control records including specimens or

copies

3570 21 CFR 211.100(a) Approval and review of procedures

1787 21 CFR 211.80(a) Procedures To Be in Writing

1767 21 CFR 211.137(a) Expiration date lacking

2028 21 CFR 211.192 Extent of discrepancy, failure investigations

1227 21 CFR 211.67(c) Cleaning/maintenance records not kept

9001 21 CFR 211.22(a) Lack of quality control unit

1912 21 CFR 211.166(a) Written program not followed

1833 21 CFR 211.84(d)(1) Identity Testing of Each Component

4303 21 CFR 211.67 b) Written procedures fail to include

1885 21 CFR 211.165(b) Microbiological testing

1920 21 CFR 211.166a)(3) Valid stability test methods

3602 21 CFR 211.160(a) Deviations from laboratory control requirements

3572 21 CFR 211.100(b) Procedure Deviations Recorded and Justified

1809 21 CFR 211.160(a) Following/documenting laboratory controls

1540 21 CFR 211.125(a) Strict control not exercised over labeling issued

1451 21 CFR 211.113(b) Procedures for sterile drug products

2031 21 CFR 211.194(a) Complete test data included in records

4413 21 CFR 211.194(a)(8) Second person sign off

4340 21 CFR 211.142 Written warehousing procedures

established/followed
3571 21 CFR 211.100(a) Changes to Procedures Not Reviewed, Approved

6732 21 CFR 314.80(c)(1)(i) Late submission of 15-day report

2007 21 CFR 211.186(a) Signature and checking of records -- 2 persons

1942 21 CFR 211.180(e) Records reviewed annually

1450 21 CFR 211.113(a) Procedures for non-sterile drug products

2034 21 CFR 211.194(d) Laboratory equipment calibration records

1975 21 CFR 211.182 Written records kept in individual logs

1550 21 CFR 211.125(f) Procedures Written and Followed

6730 21 CFR 314.80(b) Failure to develop written procedures

4402 21 CFR 211.192 Written record of investigation incomplete

2619 21 CFR 211.198(b)(2) Complaint Investigation/Follow-Up Findings

1810 21 CFR 211.160(a) Lab controls established, including changes

4406 21 CFR 211.194(a)(2) Suitability of testing methods verified

4368 21 CFR 211.188(b)(12) Investigations made into any unexplained

discrepancy

4306 21 CFR 211.80(a) Written Procedures Not Followed

1891 21 CFR 211.165(f) Failing drug products not rejected

1626 21 CFR 211.130 Procedures are written, and followed

1111 21 CFR 211.25(a) Training , Education , Experience overall

4336 21 CFR 211.150 Written distribution procedure

3583 21 CFR 211.110(a) Written in-process control procedures

3547 21 CFR 211.46(b) Equipment for Environmental Control

1801 21 CFR 211.84(a) Components withheld from use pending release

3565 21 CFR 211.58 Buildings not maintained in good state of repair

1261 21 CFR 211.68(a) Written calibration / inspection records not kept

4401 21 CFR 211.186(b)(9) Complete instructions, procedures, specifications

et. al.

4342 21 CFR 211.142(b) Storage under appropriate conditions

4307 21 CFR 211.80(d) Status of Each Lot Identified

2205 21 CFR 211.186(b)(9) Manufacturing Instructions and Specifications

1926 21 CFR 211.166(b) Adequate number of batches on stability

1495 21 CFR 211.122(a) Written procedures describing in detail

1452 21 CFR 211.113(b) Validation lacking for sterile drug products

1395 21 CFR 211.103 Actual vs. theoretical yields not determined

1134 21 CFR 211.25(b) Supervisor Training/Education/Experience

4373 21 CFR 211.188(b)(7) Actual yield, % of theoretical yield

4369 21 CFR 211.188(b)(11) Identification of persons involved, each significant

step

3613 21 CFR 211.160(b)(4) Establishment of calibration procedures

1448 21 CFR 211.111 Establishment of time limitations

8911 21 CFR 314.81(b)(1)(ii) Failure to meet specifications

4366 21 CFR 211.188(a) Accurate reproduction included

2008 21 CFR 211.186(a) Written procedures followed

2003 21 CFR 211.184(c) Individual inventory record

1886 21 CFR 211.165(c) Sampling and testing plans not described

4357 21 CFR 211.166(a) Results not used for expiration dates, storage
cond.

4353 21 CFR 211.160(b)(4) Instruments, apparatus, et. al. not meeting specs

3639 21 CFR 211.204 Returned drug procedures in writing and followed

1263 21 CFR 211.68(b) Computer control of master formula records

6831 21 CFR 314.80(c)(2) Late submission of quarterly safety reports

4380 21 CFR 211.198(b)(3) Determination not to conduct investigation of

complaint

4315 21 CFR 211.84(d)(2) Testing Each Component for Conformity with

Specs

3592 21 CFR 211.110(c) In-process materials characteristics testing

3561 21 CFR 211.56(b) Written sanitation procedures lacking

2033 21 CFR 211.194(c) Testing and standardization of standards et. al.

2001 21 CFR 211.184(b) Component Test Records

1976 21 CFR 211.182 Specific information required in individual logs

1505 21 CFR 211.122(d) Label storage access limited to authorized

personnel

1388 21 CFR 211.101(d) Component addition checked by 2nd person

4418 21 CFR 211.42(b) Adequate space lacking to prevent mix-ups and

contamination

4399 21 CFR 211.186(b)(7) Theoretical yield statement including

percentages

4378 21 CFR 211.188(b)(2) Identity of major equipment and lines used

4377 21 CFR 211.188(b(3) Identification of each component or in-process

material
 4370 21 CFR 211.188(b)(10) Records of any sampling performed

3623 21 CFR 211.170(a) Active ingredient retained sample kept

3582 21 CFR 211.105(a) Identification of containers, lines, equipment

3559 21 CFR 211.56(a) Sanitation--buildings not clean, free of infestation

1790 21 CFR 211.80(b) Handling and Storage to Prevent Contamination

1454 21 CFR 211.115(a) Reprocessing procedures not written or followed

1270 21 CFR 211.68(b) input/output verification

1169 21 CFR 211.42(a) Buildings of Suitable Size, Construction, Location

1162 21 CFR 211.28(a) Protective Apparel Not Worn

1033 21 CFR 211.22(a) Authority lacking to review records, investigate

errors

10021 21 CFR 314.98(a) (Flag to indicate ANDA applicant)

4410 21 CFR 211.194(a)(5) Calculations performed are in the records

4388 21 CFR 211.198(a) Complaints reviewed by Quality Control Unit

3632 21 CFR 211.170(b) Annual visual exams of drug products

1922 21 CFR 211.166(a)(4) Testing in same container - closure system

1802 21 CFR 211.84(b) Representative Samples

1637 21 CFR 211.130(e) Packaging line inspection after use

1633 21 CFR 211.130(d) Examination of packaging and labeling

1434 21 CFR 211.42(c)(10)(iv Environmental Monitoring System

1194 21 CFR 211.42(c) Defined areas of adequate size for operations

6832 21 CFR 314.80(c)(2) Late submission of annual safety reports

6823 21 CFR 314.80(c) Failure by applicant to report ADE

4412 21 CFR 211.194(a)(7) Signatures and dates--person who performs test

4400 21 CFR 211.186(b)(8) Description of containers, labels, et. al.

4375 21 CFR 211.188(b)(5) In-process and laboratory control results

4367 21 CFR 211.188(b)(13) Examinations for correct labeling

4338 21 CFR 211.150(b) Recall facilitation

3629 21 CFR 211.170(b) Reserve samples identified, representative,

stored

3616 21 CFR 211.165(d) Acceptance criteria for sampling & testing

3445 21 CFR 211.65(a) Equipment construction - reactive surfaces

2401 21 CFR 211.194(a)(4) Complete Test Data

2200 21 CFR 211.186(b)(4) Variation in the Amount of Components Used

2044 21 CFR 211.196 Distribution Record Requirements

1844 21 CFR 211.84(d)(2) Establish reliability of supplier's C of A

1798 21 CFR 211.82(b) Quarantine Storage of Components

1774 21 CFR 211.142(a) Quarantine - actual practice

1632 21 CFR 211.130(c) Lot or control number assigned

1546 21 CFR 211.125(d) Destruction of excess labels with lot numbers

1393 21 CFR 211.103 Yield calculations not verified by 2nd person

1168 21 CFR 211.34 Consultant Records

1098 21 CFR 211.22(c) Approve or reject procedures or specs

1049 21 CFR 211.22(a) Approve or reject components, products

8907 21 CFR 314.81(b)(1)(ii) Contamination, chemical or physical change,

deterioration

4405 21 CFR 211.194(a)(2) Statement of methods and data

4404 21 CFR 211.194(a)(1) Sample identification and other information

4374 21 CFR 211.188(b)(6) Inspection of packaging and labeling area

4354 21 CFR 211.165(d) Acceptance/Rejection Levels

4323 21 CFR 211.115(a) Reprocessing procedures lack steps to be taken

4320 21 CFR 211.84(d)(6) Microbiological Contamination Exam

3594 21 CFR 211.110(d) Rejected in-process materials not quarantined

3548 21 CFR 211.46(c) Air filtration system lacking in production area

2618 21 CFR 211.198(b)(1) Complaint Record required information

2420 21 CFR 211.198(a) Quality Control Review

2203 21 CFR 211.186(b)(7) Theoretical Yield and Percentages

2035 21 CFR 211.194(e) Stability testing records not included

1957 21 CFR 211.180(e)(2) Review of problem drugs

1928 21 CFR 211.166(c)(1) Homeopathic drugs, assessment of stability

1918 21 CFR 211.166(a)(2) Stability sample storage conditions described

1917 21 CFR 211.166(a)(1) Sample size - test intervals

1879 21 CFR 211.180(c) Records not made readily available to FDA

1869 21 CFR 211.94(c) Containers & Closures Clean, Sterilized,
Pyrogen-free

1791 21 CFR 211.80(c) Storage off Floor, Spaced Suitably

1725 21 CFR 211.134(c) Examinations documented

8912 21 CFR 314.81(b)(2) Timely submission

6736 21 CFR 314.80(c)(1)(ii) Submission of report follow-up

4409 21 CFR 211.194(a)(4) Data secured in course of each test

4371 21 CFR 211.188(b)(9) Description of containers and closures

4364 21 CFR 211.176 Failing to test for penicillin cross-contamination

4343 21 CFR 211.160(b)(1) Incoming lots - conformance to written specs-

4324 21 CFR 211.110(b) In-process materials specifications testing

4322 21 CFR 211.101(d) Component release checked by 2nd person

3591 21 CFR 211.110(b) In-process materials specifications

3569 21 CFR 211.89 Quarantine of Rejected Components et. al.

2567 21 CFR 211.198(a) Adverse Drug Experience

1927 21 CFR 211.166(b) Accelerated stability studies

1851 21 CFR 211.84(e) Rejecting When Specifications Not Met

1803 21 CFR 211.84(b) Representative Samples Criteria

1797 21 CFR 211.82(a) Examination on receipt, before acceptance

1636 21 CFR 211.130(e) Packaging line inspection before use

1449 21 CFR 211.111 Deviations of production time limits

1411 21 CFR 211.105(b) Distinctive ID or code not recorded in batch

record

1396 21 CFR 211.42(c)(2) Rejected Material Area

1266 21 CFR 211.42(d) Penicillin processing area not kept separate

1086 21 CFR 211.22(b) Adequate lab facilities not available

1079 21 CFR 211.22(a) Contract drug products--lack of responsibility

6840 21 CFR 314.80(f)(1) Wrong form - domestic ADE

6829 21 CFR 314.80(c)(2) Failure to report non-alert ADEs

6735 21 CFR 314.80(c)(1)(ii) Failure to investigate serious, unexpected events

4414 21 CFR 211.204 Record information maintained

4411 21 CFR 211.194(a)(6) Test results, comparison with standards not

included
4408 21 CFR 211.194(a)(3) Weight or measure of sample

4382 21 CFR 211.198(b)(2) Written record of complaint to include findings,

follow-up

4376 21 CFR 211.188(b)(4) Weights and measures of components used

4359 21 CFR 211.170(a)(1), (bRetention time of reserve samples, in general

4356 21 CFR 211.166(b) Tentative expiration date

4355 21 CFR 211.165(c) Sampling and testing plans not followed

4350 21 CFR 211.160(b)(3) Drug products-sampling

procedures/specifications

4341 21 CFR 211.142(a) Quarantine - written procedures

4327 21 CFR 211.122(c) Records fail to include

4325 21 CFR 211.110(a) Control procedures fail to include the following

4316 21 CFR 211.84(d)(3) Testing Containers & Closures Conformity with

Specs

4304 21 CFR 211.68(b) Written record not kept of program and validation
data

3630 21 CFR 211.170(b) Drug product reserve containers

3581 21 CFR 211.101(d) Verification of component addition

3573 21 CFR 211.101(b) Measured components for manufacturing

3557 21 CFR 211.52 Washing and toilet facilities are deficient

2032 21 CFR 211.194(b) Test method modification records not maintained

1977 21 CFR 211.182 Dedicated equipment: records part of batch

record

1958 21 CFR 211.180(f) Responsible firm officials notified in writing

1933 21 CFR 211.167(a) Sterility/pyrogens - test methods written, followed

1876 21 CFR 211.180(a), (b) Record maintenance 1 year (except exempt

OTC)

1868 21 CFR 211.94(b) Protection from external factors

1724 21 CFR 211.134(b) Representative samples after completion

1496 21 CFR 211.122(a) Sampling/testing of labeling/packaging materials

1456 21 CFR 211.115(b) Reprocessing/quality control unit

1413 21 CFR 211.42(c)(5) Mfg / Processing Operations Area

1159 21 CFR 211.28(a) Clothing appropriate for duties performed

1136 21 CFR 211.25(c) Inadequate number of personnel

6830 21 CFR 314.80(c)(2) Interval

6728 21 CFR 314.80(b) Failure to review ADE information

4417 21 CFR 211.204 Associated batches implicated, investigated

4416 21 CFR 211.204 Reprocessed returned drug products

4415 21 CFR 211.204 Returned drug products with doubt cast as to

safety et. al.

4407 21 CFR 211.194(a)(2) Reference and method not stated

4386 21 CFR 211.198(b) Written complaint record to be maintained at

facility

4345 21 CFR 211.160(b)(1) Samples (various types) representative, identified

properly

4330 21 CFR 211.130(e) Packaging line inspection documentation

4328 21 CFR 211.122(a) Written procedures not followed

4321 21 CFR 211.101(b) Identification of new containers

4317 21 CFR 211.84(d)(3) Certificates of Testing (Containers, Closures)

4302 21 CFR 211.56(b) Written sanitation procedures not followed

3641 21 CFR 211.204 Record information inclusions

3631 21 CFR 211.170(b) Investigation of reserve sample deterioration

3614 21 CFR 211.160(b)(4) Written calibration procedures

3611 21 CFR 211.160(b)(3) Acceptance of drug products

3560 21 CFR 211.56(a) Trash and organic waste timely disposal

3553 21 CFR 211.48(a) Plumbing System Defects

3551 21 CFR 211.46(d) Penicillin air handling systems not kept separate

2024 21 CFR 211.188(b)(12) Documentation of Batch Investigations

2020 21 CFR 211.188(b)(8) Labeling Control Records and Label Copies

2019 21 CFR 211.188(b)(7) Documentation of Actual Yield and Theoretical

Yield

2004 21 CFR 211.184(d) Labeling: documentation of exam and review

1978 21 CFR 211.182 Personnel dating/signing equipment log

1938 21 CFR 211.167(c) Controlled release dosage form testing

1852 21 CFR 211.94(a) Reactive/Additive/Absorptive

Containers/Closures

1842 21 CFR 211.84(d)(1) Component identity verification

1796 21 CFR 211.80(d) Identification of Each Lot in Each Shipment

1794 21 CFR 211.80(d) Disposition recorded by lot identification

1777 21 CFR 211.150(b) Distribution Recall System

1728 21 CFR 211.87 Retest of approved

components/containers/closures
1722 21 CFR 211.134(a) Correct labels during finishing operations

1630 21 CFR 211.130(b) Unlabeled filled containers controls

1509 21 CFR 211.122(h) Printing devices

1498 21 CFR 211.122(b) Labeling and packaging improperly

approved/released

1433 21 CFR 211.42(c)(10)(iii Air Supply

1409 21 CFR 211.42(c)(4) In-Process Material Area

1384 21 CFR 211.101(c) Weighing/measuring/subdividing operations

1256 21 CFR 211.68(b) Backup file not maintained

1224 21 CFR 211.67(b)(6) Cleaning SOP/inspection

1220 21 CFR 211.67(b)(3) Cleaning SOPs/instructions

8914 21 CFR 314.81(b)(2)(iv)( Mfg and control changes not requiring a

supplemental app.

8910 21 CFR 314.81(b)(2)(iii) Labeling information

8906 21 CFR 314.81(b)(1)(i) Mix-up

6838 21 CFR 314.80(e)(1) Failure to report post-marketing study ADEs

6835 21 CFR 314.80(d)(1) Failure to submit scientific article

6833 21 CFR 314.80(c)(2)(ii) Incomplete periodic safety report

6826 21 CFR 314.80(c)(1)(iii) Records not maintained by non-applicant

6825 21 CFR 314.80(c)(1)(iii) Non-applicant reports to applicant

6737 21 CFR 314.80(c)(1)(ii) Failure to separately submit original and follow-

up reports

6714 21 CFR 310.305(c)(3) Untimely submission by packer/distributor

6710 21 CFR 310.305(c)(2) Submission of report follow-up

6709 21 CFR 310.305(c)(2) Investigation of serious, unexpected events

6706 21 CFR 310.305(c)(1)(i) Late submission

6705 21 CFR 310.305(c) Failure to report

4403 21 CFR 211.194(b) Test method modification records do not include

4396 21 CFR 211.186(b)(4) Variations in component amounts not justified

4392 21 CFR 211.186(b)(1) Name, strength, dosage form

4387 21 CFR 211.198(a) Reporting of adverse drug experience to FDA

4383 21 CFR 211.198(b)(1) Written complaint record must include

4381 21 CFR 211.198(b)(2) Written investigation record or copy kept at

establishment
4379 21 CFR 211.188(b)(1) Dates not included for each significant step

4362 21 CFR 211.170(a)(3), (bRetention time for exempt OTC drug products

4360 21 CFR 211.170(b) Reserve drug product sample quantity - all tests

4351 21 CFR 211.160(b)(3) Drug products - samples representative,

identified properly

4349 21 CFR 211.160(b)(2) In-process samples representative, identified

properly

4348 21 CFR 211.160(b)(2) In-process materials - sampling, testing

procedures

4346 21 CFR 211.160(b)(1) Retesting when subject to deterioration

4344 21 CFR 211.160(b)(1) Sampling and testing procedures described

4329 21 CFR 211.122(b) Rejection of unapproved labeling/packaging

materials

4313 21 CFR 211.84(c)(6) Containers Marked to Show Samples Taken

4311 21 CFR 211.84(c)(4) Compositing of Sub Samples

3640 21 CFR 211.204 Returned drug products identified and held

3625 21 CFR 211.170(a)(1) Retention time for reserve samples of actives

3615 21 CFR 211.160(b)(4) Test devices not meeting specifications

3609 21 CFR 211.160(b)(2) In-process sample representation/identification

3608 21 CFR 211.160(b)(2) Sampling/testing of in-process materials

3598 21 CFR 211.132(b)(1) OTC products requiring tamper-evident

packaging

3589 21 CFR 211.110(a)(4) Dissolution time and rate

3588 21 CFR 211.110(a)(3) Mixing adequacy

3562 21 CFR 211.56(c) Written procedures lacking for use of pesticides

etc.

3558 21 CFR 211.52 Washing and toilet facilities not provided and
accessible

3550 21 CFR 211.46(c) Exhaust systems inadequate to control air

contamination

3546 21 CFR 211.46(a) Adequate ventilation not provided

3545 21 CFR 211.44 Adequate lighting not provided

2621 21 CFR 211.198(b)(3) Reason for Not Conducting Complaint

Investigation

2569 21 CFR 211.198(b) Maintenance of Complaint File

2406 21 CFR 211.194(a)(8) Identification of Person Performing Review of Lab

Records

2405 21 CFR 211.194(a)(7) Identification of Person Performing the Testing

2199 21 CFR 211.186(b)(4) Component Weight and Measure

2197 21 CFR 211.186(b)(2) Active Ingredient Name and Weight

2089 21 CFR 211.208 No records maintained

2086 21 CFR 211.208 Salvaging and return to marketplace

2023 21 CFR 211.188(b)(11) Identification of Persons Performing Significant

Steps

2018 21 CFR 211.188(b)(6) Documentation of Packaging and Labeling Area

Inspections

2011 21 CFR 211.188(a) Accurate reproduction

2005 21 CFR 211.184(e) Records of disposition of rejected material

1979 21 CFR 211.182 Chronological Order of Equipment Log Entries

1929 21 CFR 211.166(c)(2) Homeopathic drugs, same container - closure

1870 21 CFR 211.94(d) Written Procedures to Remove Pyrogens

1843 21 CFR 211.84(d)(2) Component written specification

1819 21 CFR 211.84(c)(3) Sterile/Aseptic Techniques for Sampling

1768 21 CFR 211.137(b) Storage conditions

1726 21 CFR 211.86 Rotation of components/containers/closures

1629 21 CFR 211.130(a) Prevention of cross contamination, mix-ups

1545 21 CFR 211.125(c) Label reconciliation discrepancies

evaluation/investigation
1503 21 CFR 211.122(c) Records not kept for each shipment

1436 21 CFR 211.42(c)(10)(vi Equipment to control conditions

1435 21 CFR 211.42(c)(10)(v) Cleaning System

1430 21 CFR 211.42(c)(10)(i) Floors, walls, ceiling surfaces

1421 21 CFR 211.42(c)(10) Aseptic Processing Area

1420 21 CFR 211.42(c)(9) Control / Lab Operations Area

1418 21 CFR 211.42(c)(7) Quarantined Drug Products Area

1371 21 CFR 211.101(a) Batches Formulated to less than 100%

1251 21 CFR 211.42(c)(1) Incoming material area

1219 21 CFR 211.67(b)(2) Cleaning SOPs/schedules

1174 21 CFR 211.42(b) Product flow through building is inadequate

1167 21 CFR 211.34 Qualifications lacking

1164 21 CFR 211.28(c) Unauthorized Personnel in Limited Access Areas

1163 21 CFR 211.28(b) Habits of good sanitation & health

Long Desc

The responsibilities and procedures applicable to the quality control unit are not [in writing] [fully followed]. Specifically, ***

Control procedures are not established which [monitor the output] [validate the performance] of those manufacturing processes that may be
responsible for causing variability in the characteristics of in-process material and the drug product. Specifically, ***

There is a failure to thoroughly review [any unexplained discrepancy] [the failure of a batch or any of its components to meet any of its
specifications] whether or not the batch has been already distributed. Specifically, ***

Laboratory controls do not include the establishment of scientifically sound and appropriate [specifications] [standards] [sampling plans] [test
procedures] designed to assure that [components] [drug product containers] [closures] [in-process materials] [labeling] [drug products]
conform to appropriate standards of identity, strength, quality and purity. Specifically, ***

There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength,
quality, and purity they purport or are represented to possess. Specifically, ***

Written production and process control procedures are not [followed in the execution of production and process control functions]
[documented at the time of performance]. Specifically, ***

Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the
[final specifications] [identity and strength of each active ingredient] prior to release. Specifically, ***

Batch production and control records [are not prepared for each batch of drug product produced] [do not include complete information
relating to the production and control of each batch]. Specifically, ***

Employees are not given training in [the particular operations they perform as part of their function] [current good manufacturing practices]
[written procedures required by current good manufacturing practice regulations]. Specifically, ***

Written procedures are not [established] [followed] for the cleaning and maintenance of equipment, including utensils, used in the
manufacture, processing, packing or holding of a drug product. Specifically, ***

Procedures describing the handling of written and oral complaints related to drug products are [not written or followed] [deficiently written or
followed]. Specifically, ***

Equipment and utensils are not [cleaned] [maintained] [sanitized] at appropriate intervals to prevent [malfunctions] [contamination] that
would alter the safety, identity, strength, quality or purity of the drug product. Specifically, ***

Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written
specifications, without [performing at least one specific identity test on each component] [establishing the reliability of the supplier's analyses
through appropriate validation of the supplier's test results at appropriate intervals]. Specifically, ***

Written procedures are not [established] [followed] for evaluations conducted at least annually to review records associated with a
representative number of batches, whether approved or rejected. Specifically, ***
Written records are not [always] made of investigations into [unexplained discrepancies] [the failure of a batch or any of its components to
meet specifications]. Specifically, ***

Routine [calibration] [inspection] [checking] of [automatic] [mechanical] [electronic] equipment is not performed according to a written
program designed to assure proper performance. Specifically, ***

Drug product production and control records, are not [reviewed] [approved] by the quality control unit to determine compliance with all
established, approved written procedures before a batch is released or distributed. Specifically, ***

The [accuracy] [sensitivity] [specificity] [reproducibility] of test methods have not been [established] [documented]. Specifically, ***

Equipment used in the manufacture, processing, packing or holding of drug products is not [of appropriate design] [of adequate size]
[suitably located] to facilitate operations for its [intended use] [cleaning and maintenance]. Specifically, ***

There is no written testing program designed to assess the stability characteristics of drug products. Specifically, ***

Procedures describing the handling of all written and oral complaints regarding a drug product are not [established] [written] [followed].
Specifically, ***

Written procedures are not [established] [followed] for evaluations done at least annually and including provisions for a review of
[complaints] [recalls] [returned or salvaged drug products] [investigations conducted for each drug product]. Specifically, ***

GMP training is not conducted [on a continuing basis] [with sufficient frequency] to assure that employees remain familiar with CGMP
requirements applicable to them. Specifically, ***

The calibration of [instruments] [apparatus] [gauges] [recording devices] is not done at suitable intervals [in accordance with an established
written program] [with provisions for remedial action in the event accuracy and/or precision limits are not met]. Specifically, ***

Batch production and control records do not include complete labeling control records, including specimens or copies of all labeling used for
each batch of drug product produced. Specifically, ***

Written procedures are not [drafted, reviewed and approved by the appropriate organizational units] [reviewed and approved by the quality
control unit]. Specifically, ***

Written procedures are lacking which describe in sufficient detail the [receipt] [identification] [storage] [handling] [sampling] [testing]
[approval] [rejection] of [components] [drug product containers] [closures]. Specifically, ***

Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity,
strength, quality and purity at the time of use. Specifically, ***

Investigations of [an unexplained discrepancy] [a failure of a batch or any of its components to meet any of its specifications] did not extend
to [other batches of the same drug product] [other drug products that may have been associated with the specific failure or discrepancy].
Specifically, ***
Records are not kept for the [maintenance] [cleaning] [sanitizing] [inspection] of equipment. Specifically, ***

There is no quality control unit. Specifically, ***

The written stability testing program is not followed. Specifically, ***

The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity
tests if they exist. Specifically, ***

Written procedures for cleaning and maintenance fail to include [assignment of responsibility] [maintenance and cleaning schedules]
[description in sufficient detail of methods, equipment and materials used] [description in sufficient detail of the methods of disassembling
and reassembling equipment as necessary to assure proper cleaning and maintenance] [instructions for removal or obliteration of previous
batch identification] [instructions for protection of clean equipment from contamination prior to use] [parameters relevant to the operation].
Specifically, ***
Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.
Specifically, ***

The written stability program for drug products does not include [reliable] [meaningful] [specific] test methods. Specifically, ***

Deviations from written [specifications] [standards] [sampling plans] [test procedures] [laboratory mechanisms] are not [recorded] [justified].
Specifically, ***

Deviations from written production and process control procedures are not [recorded] [justified]. Specifically, ***

Established [specifications] [standards] [sampling plans] [test procedures] [laboratory control mechanisms] are not [followed] [documented at
the time of performance]. Specifically, ***

Strict control is not exercised over labeling issued for use in drug product labeling operations. Specifically, ***

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not [established] [written]
[followed]. Specifically, ***

Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with
established specifications and standards. Specifically, , ***

Laboratory records do not include the initials or signature of a second person showing that the original records have been reviewed for
[accuracy] [completeness] [compliance with established standards]. Specifically, ***

Procedures describing the warehousing of drug products are not [established] [followed]. Specifically, ***
Changes to written procedures are not [drafted, reviewed and approved by the appropriate organizational unit] [reviewed and approved by
the quality control unit]. Specifically, ***

Not all adverse drug experiences that are both serious and unexpected have been reported to FDA within 15 calendar days of initial receipt
of the information. Specifically, ***

The master production and control records for each batch size of drug product are not [prepared, dated, and signed by one person with a
full handwritten signature] [independently checked, dated, and signed by a second person]. Specifically, ***

Records are not maintained so that data therein can be reviewed at least annually to evaluate the quality standards of each drug product to
determine the need for changes in specifications or manufacturing or control procedures. Specifically, ***

Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not [established] [written]
[followed]. Specifically, ***

Laboratory records do not include complete records of the periodic calibration of laboratory [instruments] [apparatus] [gauges] [recording
devices]. Specifically, ***

Written records of major equipment [cleaning] [maintenance] [use] are not included in individual equipment logs. Specifically, ***

Procedures describing in sufficient detail the controls employed for the issuance of labeling are not [written] [followed]. Specifically, ***

Written procedures have not been developed for the [surveillance] [receipt] [evaluation] [reporting to FDA] of post marketing adverse drug
experiences. Specifically, ***

Written records of investigations into [unexplained discrepancies] [the failure of a batch or any of its components to meet specifications] do
not [always] include the conclusions and follow-up. Specifically, ***

Complaint records are deficient in that they do not include the findings of the [investigation] [follow-up]. Specifically, ***

The establishment of [specifications] [standards] [sampling plans] [test procedures] [laboratory control mechanisms] including any changes
thereto, are not [drafted by the appropriate organizational unit] [reviewed and approved by the quality control unit]. Specifically, ***

The suitability of all testing methods is not verified under actual conditions of use. Specifically, ***

Batch production and control records do not include the results of any investigation made into any unexplained discrepancy, whether or not
the batch of drug product had already been distributed. Specifically, ***

Written procedures are not followed for the [receipt] [identification] [storage] [handling] [sampling] [testing] [approval] [rejection] of
[components] [drug product containers] [closures]. Specifically, ***
Drug products failing to meet established [standards] [specifications] [quality control criteria] are not rejected. Specifically, ***

Procedures designed to assure that correct [labels] [labeling] [packaging materials] are used for drug products are not [written] [followed].
Specifically, ***

Employees engaged in the [manufacture] [processing] [packing] [holding] of a drug product lack the [education] [training] [experience]
required to perform their assigned functions. Specifically, ***

Written distribution procedures are not [established] [followed]. Specifically, ***

Written procedures are not [established] [followed] that describe the [in-process controls] [tests] [examinations] to be conducted on
appropriate samples of in-process materials of each batch. Specifically, ***

Equipment for adequate control over [air pressure] [micro-organisms] [dust] [humidity] [temperature] is not provided when appropriate for the
manufacture, processing, packing or holding of a drug product. Specifically, ***

Each lot of [components] [drug product containers] [closures] is not withheld from use until the lot has been sampled, tested, examined, and
released by the quality control unit. Specifically, ***

Buildings used in the [manufacturing] [processing] [packing] [holding] of a drug product are not maintained in a good state of repair.
Specifically, ***

Records of the [calibration checks] [inspections] of automatic, mechanical or electronic equipment, including computers or related systems
are not maintained. Specifically, ***

Master production and control records lack [complete manufacturing and control instructions] [sampling and testing procedures]
[specifications] [special notations] [precautions to be followed]. Specifically, ***

Drug products are not stored under appropriate conditions of [temperature] [humidity] [light] so that their identity, strength, quality, and purity
are not affected. Specifically, ***

Each lot of [components] [drug product containers] [closures] was not appropriately identified as to its status in terms of being quarantined,
approved or rejected. Specifically, ***

The master production and control records are deficient in that they do not include complete [manufacturing] [control] [instructions]
[sampling] [testing] [procedures] [specifications] [special notations] [precautions]. Specifically, ***

An adequate number of batches of each drug product are not tested [nor are records of such data maintained] to determine an appropriate
expiration date. Specifically, ***

There is a lack of written procedures describing in sufficient detail the [receipt] [identification] [storage] [handling] [sampling] [examination]
[testing] of labeling and packaging materials. Specifically, ***
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include [adequate] validation
of the sterilization process. Specifically, ***

Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate phase of [manufacturing]
[processing] [packaging] [holding] of the drug product. Specifically, ***

Individuals responsible for supervising the [manufacture] [processing] [packing] [holding] of a drug product lack the [education] [training]
[experience] to perform their assigned functions in such a manner as to assure the drug product has the safety, identity, strength, quality and
purity that it purports or is represented to possess. Specifically, ***

The batch production and control records do not include a statement of the [actual yield] [percentage of theoretical yield] at appropriate
stages of processing for each batch of drug product produced. Specifically, ***

Batch production and control records do not include the identification of the persons [performing] [directly supervising] [checking] each
significant step in the operation, for each batch of drug product produced. Specifically, ***

Procedures describing the calibration of instruments, apparatus, gauges and recording devices are [not written or followed] [deficiently
written or followed]. Specifically, ***

Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product.
Specifically, ***

An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning a failure of one or more
distributed batches of a drug to meet the specifications established for it in the application. Specifically, ***

Batch production and control records for each batch of drug product produced do not include an accurate reproduction of the appropriate
master production or control record which was checked for accuracy, dated and signed. Specifically, ***

Procedures for the preparation of master production and control records are not [described in a written procedure] [followed]. Specifically,
***

Records fail to include an individual inventory record of each [component] [reconciliation of the use of each component] [drug product
container] [drug product closure] with sufficient information to allow determination of any associated batch or lot of drug product.
Specifically, ***

Sampling and testing plans for drug products are not described in written procedures which include the [method of sampling] [number of
units per batch to be tested]. Specifically, ***

Results of stability testing are not used in determining [appropriate storage conditions] [expiration dates]. Specifically, ***

The use of [instruments] [apparatus] [gauges] [recording devices] not meeting established specifications was observed. Specifically, ***

Procedures describing the [holding] [testing] [reprocessing] of returned drug products are not [in writing] [followed]. Specifically, ***
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records
or other records are instituted only by authorized personnel. Specifically, ***

Not all quarterly periodic adverse drug experience reports have been submitted within 30 days of the close of the quarter. Specifically, ***

The written record did not include the [reason an investigation was found not to be necessary] [name of the responsible person making the
determination not to conduct an investigation] when an investigation into [unexplained discrepancies] [the failure of a batch or any of its
components to meet specifications] was not conducted. Specifically, ***

Each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality. Specifically, ***

In-process materials are not tested for [identity] [strength] [quality] [purity] and approved or rejected by the quality control unit [during the
production process] [after storage for long periods]. Specifically, ***

There is a lack of written procedures [assigning responsibility] [providing cleaning schedules] [describing in sufficient detail the methods,
equipment and materials to be used] for sanitation. Specifically, ***

Laboratory records do not include complete records of any testing and standardization of laboratory [reference standards] [reagents]
[standard solutions]. Specifically, ***

The [component] [drug product container] [closure] [labeling] records do not include the [results of tests or examinations performed] [the
conclusions derived from tests or examinations performed]. Specifically, ***

Individual equipment logs do not show [time] [date] [product] [lot number of each batch processed]. Specifically, ***

Access to the storage area for labels and labeling materials is not limited to authorized personnel. Specifically, ***

Each component is not added to a batch by one person and verified by a second person. Specifically, ***

The building lacks adequate space for the orderly placement of equipment and materials to prevent mix-ups between [different components]
[drug product containers] [closures] [labeling] [in-process materials] [drug products] and to prevent contamination. Specifically, ***

Master production and control records lack a statement of theoretical yield [including the maximum and minimum percentages of theoretical
yield beyond which investigation is required]. Specifically, ***

Batch production and control records do not include the identity of individual major [equipment] [lines] used for each batch of drug product
produced. Specifically, ***

Batch production and control records do not include the specific identification of each batch of [component] [in-process material] used for
each batch of drug product produced. Specifically, ***
Batch production and control records do not include a record of any sampling performed, for each batch of drug product produced.
Specifically, ***

A sample which is representative of each lot in each shipment of each active ingredient is not [appropriately identified] [retained].
Specifically, ***

All [compounding and storage containers] [processing lines] [major equipment] used during the production of a batch of drug product is not
properly identified at all times to indicate [contents] [the phase of processing of the batch]. Specifically, ***

Buildings used in the manufacture, processing, packing or holding of drug products are not [maintained in a clean and sanitary condition]
[free of infestation by rodents, birds insects, and other vermin]. Specifically, ***

There was a failure to handle and store [components] [drug product containers] [closures] at all times in a manner to prevent contamination.
Specifically, ***

Procedures prescribing a system for reprocessing batches to insure that the reprocessed batches will conform with all established
standards, specifications, and characteristics are not [written] [followed]. Specifically, ***

Input to and output from [the computer] [related systems of formulas] [records or data] are not checked for accuracy. Specifically, ***

Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable [size] [construction] [location]
to facilitate cleaning, maintenance, and proper operations. Specifically, ***

Protective apparel is not worn as necessary to protect drug products from contamination. Specifically, ***

The quality control unit lacks authority to [review production records to assure that no errors have occurred] [fully investigate errors that
have occurred]. Specifically, ***

(DO NOT PRINT ON FDA 483. This cite is to be used as a flag to indicate that the recipient of an FDA 483 involving ADE reporting is the
applicant for one or more approved ANDAs, as opposed to approved NDAs. No specifics text is required for this cite.)

Laboratory records do not include a record of all calculations performed in connection with the test. Specifically, ***

Written procedures describing the handling of complaints do not include provisions for [review by the quality control unit of any complaint
involving the possible failure of a drug product to meet any of its specifications] [a determination as to the need for an investigation of any
unexplained discrepancy] [explaining the reasons for the failure of the batch or any of its components to meet specifications]. Specifically,
***

Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not
examined visually at least once a year for evidence of deterioration. Specifically, ***

The written stability program does not assure testing of the drug product in the same container-closure system as that in which the drug
product is marketed. Specifically, ***
Representative samples are not taken of each shipment of each lot of [components] [drug product containers] [closures] for testing or
examination. Specifically, ***

Inspection of the [packaging] [labeling] facilities is not done after use to assure that materials not suitable for subsequent operations have
been removed. Specifically, ***

Examination of packaging and labeling materials for suitability and correctness before packaging operations is [not performed] [not
documented in the batch production records]. Specifically, ***

Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. Specifically, ***

The [separate or defined areas][control systems] necessary to prevent contamination or mix-ups are deficient. Specifically, ***

Not all annual periodic adverse drug experience reports have been submitted within 60 days of the anniversary date of the approval of the
application. Specifically, ***

Adverse drug experience information has not been reported to FDA. Specifically, ***

Laboratory records do not include [the initials or signature of the person who performs each test] [the date(s) the tests were performed].
Specifically, ***

Master production and control records lack [a description of the drug product containers, closures and packaging materials] [a specimen or
copy of each label and all other labeling] [the signatures and dates entered by the person or persons responsible for the approval of
labeling]. Specifically, ***

Batch production and control records do not include [in-process] [laboratory control] results for each batch of drug product produced.
Specifically, ***

Batch production and control records do not include results of examinations made of packaged and labeled products for correct labeling.
Specifically, ***

A system by which the distribution of each lot of drug product can be readily determined to facilitate its recall if necessary, has not been
established. Specifically, ***

Reserve drug product samples are not [appropriately identified] [representative of each lot or batch of drug product] [retained and stored
under conditions consistent with product labeling]. Specifically, ***

Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate to assure that batches of drug products
meet [each appropriate specification] [appropriate statistical quality control criteria] as a condition for their approval and release.
Specifically, ***

Equipment surfaces that contact [components] [in-process materials] [drug products] are reactive, additive or absorptive so as to alter the
safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements. Specifically, ***
Laboratory records are deficient in that they do not include a complete record of all data obtained during testing. Specifically, ***

The master production and control records are deficient in that they lack a justification for the variation in the amount of components used in
the preparation of a dosage form. Specifically, ***

Distribution records do not contain the [name and strength of the drug product] [description of dosage form] [name and address of
consignee] [date and quantity shipped] [lot or control number of drug product]. Specifically, ***

Establishment of the reliability of the component supplier's report of analyses is deficient in that the test results are not appropriately
validated at appropriate intervals. Specifically, ***

Incoming [components] [drug product containers] [closures] are not stored under quarantine until they have been tested or examined, as
appropriate, and released. Specifically, ***

Drug products are not quarantined before being released by the quality control unit. Specifically, ***

The drug product is not identified with a lot or control number that permits the determination of the history of the manufacture and control of
the batch. Specifically, ***

Excess labeling bearing lot or control numbers is not destroyed. Specifically, ***

Yield calculations are not performed by one person and independently verified by a second person. Specifically, ***

Records are not maintained stating the consultant's [name] [address] [qualifications] [type of service provided]. Specifically, ***

The quality control unit lacks responsibility to [approve] [reject] all procedures or specifications impacting on the [identity] [strength] [quality]
[purity] of drug products. Specifically, ***

The quality control unit lacks the responsibility and authority to [approve] [reject] all [components] [drug product containers] [closures] [in
process materials] [packaging material] [labeling] [drug products]. Specifically, ***

An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning [bacteriological contamination]
[significant chemical, physical, or other change or deterioration] in a distributed drug product. Specifically, ***

Laboratory records do not include a statement of [each method used in the testing of a sample] [the location of data that establish that the
methods used in the testing of the sample meet proper standards of accuracy and reliability as applied to the product tested]. Specifically,
***

Laboratory records do not include [a description of the sample received for testing] [the source or location from where the sample was
obtained] [the quantity of the sample] [the lot number or other distinctive code of the sample] [the date the sample was taken] [the date the
sample was received for testing]. Specifically, ***
Batch production and control records do not include results of the inspection of the packaging and labeling area [before] [after] use for each
batch of drug product produced. Specifically, ***

The statistical quality control criteria fail to include appropriate [acceptance levels] [rejection levels]. Specifically, ***

Reprocessing procedures lack the steps to be taken to insure that reprocessed batches will conform with all established standards,
specifications, and characteristics. Specifically, ***

Each lot of a [component] [drug product container] [closure] that is liable to microbiological contamination that is objectionable in view of its
intended use is not subjected to microbiological tests before use. Specifically, ***

Rejected in-process materials are not [identified] [controlled under a quarantine system] to prevent their use in manufacturing or processing
operations for which they are unsuitable. Specifically, ***

The production area air supply lacks an appropriate air filtration system. Specifically, ***

Complaint records are deficient in that they do not include the known [name and strength of the drug product] [lot number] [name of
complainant] [nature of complaint] [reply to complainant]. Specifically, ***

Complaint procedures are deficient in that they do not include provisions that allow for the review and determination of an investigation by
the quality control unit. Specifically, ***

The master production and control records are deficient in that they do not include a statement of theoretical yield and [minimum]
[maximum] [yield percentages]. Specifically, ***

Laboratory records do not include complete records of all stability testing performed. Specifically, ***

The procedures for the annual quality standards record evaluation are deficient in that they do not address a review of [complaint] [recall]
[returned drug product] [salvaged drug product] [investigation] records for each drug product. Specifically, ***

There is no written assessment of stability of homeopathic drug products based at least on [testing or examination of the drug product for
compatibility of the ingredients] [marketing experience with the drug product to indicate that there is no degradation of the product for the
normal or expected period of use]. Specifically, ***

The written stability program for drug products does not describe the storage conditions for samples retained for testing. Specifically, ***

The written stability program for drug products does not include [sample size] [test intervals] based on statistical criteria for each attribute
examined to assure valid estimates of stability. Specifically, ***

Records associated with drug product [components] [containers] [closures] [labeling] [production] [control] [distribution] and within the
retention period for such records, were not made readily available for authorized inspection. Specifically, ***
Drug product [containers] [closures] were not [clean] [sterilized and processed to remove pyrogenic properties] to assure that they are
suitable for their intended use. Specifically, ***

Bagged or boxed components of drug product [containers] [closures] are not [stored off the floor] [suitably spaced to allow cleaning and
inspection]. Specifically, ***

The results of the examination of the packaged and labeled products were not documented in the batch production or control records.
Specifically, ***

An annual report was not submitted [each year] [within 60 days of the anniversary date of U.S. approval of the application] to the FDA
division responsible for reviewing the application. Specifically, ***

Follow-up reports were not submitted [within 15 calendar days of receipt of new information] [as requested by FDA] concerning post
marketing 15-day reports. Specifically, ***

Laboratory records do not include a complete record of all data secured in the course of each test, including all [graphs] [charts] [spectra]
from laboratory instrumentation, properly identified to show the [specific component] [drug product container] [closure] [in-process material]
[lot tested] [drug product tested]. Specifically, ***

Batch production and control records do not include a description of drug product [containers] [closures] used for each batch of drug product
produced. Specifically, ***

Non-penicillin drug products were not tested for the presence of penicillin, when a reasonable possibility existed that a non-penicillin drug
product has been exposed to a cross-contamination with penicillin. Specifically, ***

Laboratory controls do not include determination of conformance to appropriate written specifications for the acceptance of each lot within
each shipment of [components] [drug product containers] [closures] [in-process materials] [labeling] [drug products] used in the
manufacture, processing, packing, or holding of drug products. Specifically, ***

Examination and testing of samples is not done to assure that in-process materials conform to specifications. Specifically, ***

Each container of component dispensed to manufacturing is not examined by a second person to assure that [the component was released
by the quality control unit] [the weight or measure is correct as stated in the batch records] [the containers are properly identified].
Specifically, ***

In-process specifications are not [consistent with drug product final specifications] [derived from previous acceptable process average and
process variability estimates where possible] [determined by the application of suitable statistical procedures where appropriate].
Specifically, ***

Rejected [components] [drug product containers] [closures] are not controlled under a quarantine system designed to prevent their use in
manufacturing or processing operations for which they are unsuitable. Specifically, ***

Complaint procedures are deficient in that they do not include provisions that allow for the review to determine if the complaints represent
[serious] [unexpected adverse drug experiences] which are required to be reported to FDA. Specifically, ***

Accelerated stability studies, combined with basic stability information, used to support tentative expiration dates are not supported with
ongoing full shelf life studies. Specifically, ***
Failure to reject any lot of [components] [drug product containers] [closures] that did not meet the appropriate written specifications for
identity, strength, quality, and purity. Specifically, ***

The [number of containers to be sampled] [amount of material taken from each container] is not based upon appropriate criteria.
Specifically, ***

Each container or grouping of containers of [components] [drug product containers] [closures] is not examined visually upon receipt and
before acceptance for [appropriate labeling as to contents] [container damage] [broken seals] [contamination]. Specifically, ***

Inspection of the [packaging] [labeling] facilities immediately before use is not done to assure that all drug products have been removed from
previous operations. Specifically, ***

Deviations from production time limits [are not justified] [are not documented] [compromise the quality of the drug product]. Specifically, ***

The batch records do not record the distinctive [identification number] [code] [name of equipment] to identify major equipment to show the
specific equipment used in the manufacture of a batch of a drug product. Specifically, ***

Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the holding of rejected
[components] [drug product containers] [closures] [labeling] before disposition. Specifically,***

The operations relating to the [manufacture] [processing] [packing] of penicillin are not performed in facilities separate from those used for
other drug products for human use. Specifically, ***

Adequate lab facilities for testing and approval or rejection of [components] [drug product containers] [closures] [packaging materials] [in-
process materials] [drug products] are not available to the quality control unit. Specifically, ***

The quality control unit lacks responsibility for approving or rejecting drug products [manufactured] [processed] [packed] [held] under
contract by another company. Specifically, ***

An FDA Form 3500A has not been completed for each report of a domestic adverse drug experience. Specifically, ***

Individual ADEs which were not reported to FDA in a post marketing 15-day alert have not been included in a periodic safety report.
Specifically, ***

Adverse drug experiences that were the subject of post marketing 15-day reports were not [promptly] investigated. Specifically, ***

Records of returned drug products are not maintained. Specifically, ***

Laboratory records do not include a statement of the results of tests and how the results compare with established standards of identity,
strength, quality, and purity for the [component] [drug product container] [closure] [in-process material] [drug product] tested. Specifically, ***
Laboratory records do not include a statement of the weight or measure of sample used for each test, where appropriate. Specifically, ***

Written records of investigation of a drug complaint do not include [the findings of the investigation] [the follow-up]. Specifically, ***

Batch production and control records do not include the weights and measures of components used in the course of processing each batch
of drug product produced. Specifically, ***

Reserve samples for [active ingredients] [drug products] are not retained for one year after the expiration date of the drug product.

Where data from accelerated studies was used to project a tentative expiration date beyond a date supported by actual shelf life studies,
there were no [stability studies] [drug product testing at appropriate intervals] conducted until the tentative expiration date was verified or the
appropriate expiration date determined. Specifically, ***

Written procedures for sampling and testing plans are not followed for each drug product. Specifically, ***

Laboratory controls do not include a determination of conformance to [written descriptions of sampling procedures] [appropriate
specifications] for drug products. Specifically, ***

Written procedures for the warehousing of drug products do not include quarantine of drug products before release by the quality control
unit. Specifically, ***

Records kept for each different labeling and packaging material shipment fail to include [the receipt] [results of examination or testing] [a
statement of whether the shipment was accepted or rejected]. Specifically, ***

Control procedures fail to include [tablet or capsule weight variation] [disintegration time] [adequacy of mixing to assure uniformity and
homogeneity] [dissolution time and rate] [clarity, completeness or pH of solutions]. Specifically,***

Containers and closures are not tested for conformance with all appropriate written procedures. Specifically, ***

A written record of the program along with appropriate validation data has not been maintained in situations where backup data is eliminated
by computerization or other automated processes. Specifically, ***

Drug product reserve samples are not stored in [the same immediate container-closure system as the marketed product] [an immediate
container-closure system that has essentially the same characteristics as the marketed product]. Specifically, ***

Each component is not added to the batch by one person and verified by a second person.. Specifically, ***

Components for drug product manufacturing are not [weighed] [measured] [subdivided as appropriate]. Specifically, ***
Washing and toilet facilities lack [hot and cold water] [soap or detergent] [air driers or single-service towels] [cleanliness]. Specifically, ***

Complete records are not maintained of any modification of an established method employed in testing. Specifically, ***

The records of [cleaning] [maintenance] [use] for dedicated equipment are not part of the batch record. Specifically, ***

Procedures are not established which are designed to assure that the responsible officials of the firm, if they are not personally involved in
or immediately aware of such actions, are notified in writing of [investigations conducted] [recalls] [reports of inspectional observations
issued by FDA] [any regulatory actions brought by FDA relating to good manufacturing practices]. Specifically, ***

Test procedures relative to appropriate laboratory testing for [sterility] [pyrogens] are not [written] [followed]. Specifically, ******

All records of [production] [control] [distribution] [components] [drug product containers] [closures] [labeling] associated with a batch of drug
product are not maintained at least one (1) year after the expiration date. Specifically, ***

Container closure systems do not provide adequate protection against foreseeable external factors in storage and use that can cause
deterioration or contamination of the drug product. Specifically, ***

Samples of representative units were not [collected] [visually examined] for correct labeling at the completion of finishing operations.
Specifically, ***

Labeling and packaging materials are not [representatively sampled] [examined] [tested] upon receipt and before use in packaging and
labeling of a drug product. Specifically, ***

Reprocessing was performed without the [review] [approval] of the quality control unit. Specifically, ***

Separate or defined areas to prevent contamination or mix-ups are deficient regarding the manufacturing and processing operations.
Specifically, ***

Clothing of personnel engaged in the [manufacturing] [processing] [packing] [holding] of drug products is not appropriate for the duties they
perform. Specifically, ***

The number of qualified personnel is inadequate to [perform] [supervise] the [manufacture] [processing] [packing] [holding] of each drug
product. Specifically, ***

Periodic reports of non-alert adverse drug experiences have not been submitted [quarterly for an application which was approved less than
three years ago] [yearly for an application which was approved three or more years ago]. Specifically, ***

Adverse drug experience information obtained or otherwise received from any source was not [promptly] reviewed, including information
from [commercial marketing experience] [post marketing clinical investigations] [post marketing epidemiological/surveillance activities]
[reports in the scientific literature] [unpublished scientific papers]. Specifically, ***
No appropriate investigation was conducted when a returned drug product appeared to implicate associated batches of drug products.
Specifically, ***

Returned drug products were reprocessed without assuring that the subsequent drug product met the appropriate standards of safety,
identity, strength, quality and purity. Specifically, ***

Returned drug products held, stored or shipped before or during their return under conditions which cast doubt on their safety, identity,
strength, quality or purity are not [destroyed] [subjected to examination, testing or other investigation to prove the drug products do meet all
the necessary parameters]. Specifically, ***

Laboratory records of methods of testing used do not [indicate the method] [provide the reference] when employing methods in [recognized
standard references] [an approved new drug application and the referenced method is not modified]. Specifically, ***

A written record of each complaint is not maintained in a file designated for drug product complaints [at the facility where the drug product
was manufactured, processed or packed] [at a facility other than the facility in which the drug product was manufactured, processed or
packed provided the written records are readily available for inspection at that other facility]. Specifically, ***

Samples taken to determine conformance to appropriate written specifications for the acceptance of each lot within each shipment of
[components] [drug product containers] [closures] [labeling] are not [representative] [adequately identified]. Specifically, ***

Results of inspection of packaging and labeling facilities are not documented in the batch production records. Specifically, ***

Written procedures for the [receipt] [identification] [storage] [handling] [sampling] [examination] [testing] of packaging and labeling materials
are not followed. Specifically, ***

For components removed from the original containers, the new container fails to be identified with [component name or item code] [receiving
or control number] [weight or measure] [batch for which component was dispensed including product name, strength and lot number].
Specifically, ***

Certificates of testing of [containers] [closures] are accepted in lieu of testing without [a visual identification] [establishing the reliability of the
supplier's test results through appropriate validation of the test results at appropriate intervals]. Specifically, ***

Written procedures for sanitation are not followed. Specifically, ***

Records of returned drug products do not include the [name] [labeled potency] [lot, control or batch number] [reason for return] [quantity]
[date of disposition] [ultimate disposition]. Specifically, ***

Evidence of reserve drug product sample deterioration was not [investigated] [recorded and maintained with other stability data].
Specifically, ***

Written calibration procedures for instruments, apparatus, gauges, and recording devices are deficient in that they do not include specific
[directions] [schedules] [limits for accuracy and precision] [provisions for remedial action if limits are not met]. Specifically, ***

Determinations of conformance to appropriate written specifications for acceptance are [not made] [deficient] for drug products. Specifically,
***
There is no provision to hold and dispose of [trash] [organic waste matter] in a timely and sanitary manner. Specifically, ***

The plumbing system contains defects that could contribute to the contamination of drug products. Specifically, ***

Air-handling systems for the [manufacture] [processing] [packing] of penicillin are not completely separate from those for other drug
products for human use. Specifically, ***

The batch production and control records are deficient in that they do not include documentation of batch investigations performed.
Specifically, ***

The batch production and control records are deficient in that they do not include [complete labeling control records] [specimen] [copy] of
labeling. Specifically, ***

The batch production and control records are deficient in that they do not include a statement of the [actual yield] [percentage of theoretical
yield]. Specifically, ***

There is no documentation of the examination and review of labels and labeling for conformity with [established specifications] [the
assigning of a lot or control number]. Specifically, ***

The persons [performing] [double-checking] the cleaning and maintenance are not [dating] [signing or initialing] the equipment cleaning and
use log. Specifically, ***

Each batch of controlled-release dosage form drug product is not laboratory tested to determine conformance to the specifications for the
rate of release for each active ingredient. Specifically, ***

Drug product containers or closures are [reactive] [additive] [absorptive] so as to alter the safety, identity, strength, quality, and purity of the
drug beyond the official or established requirements. Specifically, ***

Drug product component testing is deficient in that at least one specific test to verify the identity of each component is not performed.
Specifically,***

Each lot in each shipment received was not identified with a distinctive code for each container or grouping of containers for [components]
[drug product containers] [closures]. Specifically, ***

The distinctive code for each lot of [components] [drug product containers] [closures] is not used in recording the disposition of each lot.
Specifically, ***

The distribution system is deficient in that each lot of drug product cannot be readily determined to facilitate its recall if necessary.
Specifically, ***

Approved [components] [drug product containers] [closures] are not retested or reexamined as appropriate for identity, strength, quality and
purity after [storage for long periods] [exposure to conditions that might have an adverse effect] with subsequent approval or rejection by the
quality control unit. Specifically, ***
Packaged and labeled products are not examined during finishing operations to provide assurance that containers and packages in the lot
have the correct label. Specifically, ***

Filled drug product containers which are set aside and held in an unlabeled condition are not [identified] [handled] to preclude mislabeling of
individual containers, lots or portions of lots. Specifically, ***

Printing devices used to imprint labeling upon the drug product [unit label] [case] are not monitored to assure that all imprinting conforms to
the print specified in the batch production record. Specifically, ***

Labeling and packaging materials not meeting the appropriate written specifications were [approved] [released for use]. Specifically, ***

Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive
pressure. Specifically, ***

Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the storage of in-process
materials. Specifically, ***

Component [weighing] [measuring] [subdividing] operations are not adequately supervised. Specifically, ***

Failure to maintain a backup file of data entered into the computer or related system. Specifically, ***

Procedures for the cleaning and maintenance of equipment are deficient regarding inspection of the equipment for cleanliness immediately
before use. Specifically, ***

Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods, equipment, and materials
used in the cleaning and maintenance operation, and the methods of disassembly and reassembling equipment as necessary to assure
proper cleaning and maintenance. Specifically, ***

An annual report did not include a full description of the manufacturing and control changes not requiring a supplemental application, listed
by date in the order in which they were implemented. Specifically, ***

An annual report did not include [currently used professional labeling] [patient brochures or package inserts] [a representative sample of the
package labels] [a summary of any changes in labeling that have been made since the last report, listed by date in the order in which they
were implemented, or if no changes, a statement of that fact]. Specifically, ***

An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning an incident that caused a drug
product or its labeling to be [mistaken for] [applied to] another article. Specifically, ***

Fifteen-day Alert reports have not been submitted for all adverse drug experiences during post marketing studies, where there was a
reasonable possibility that the drug caused the adverse experience. Specifically, ***

Not all post marketing 15-day Alert reports based upon scientific literature were accompanied by a copy of the published article. Specifically,
***
Not all periodic reports contained [a narrative summary and analysis of the information in the report] [an analysis of the post marketing 15-
day Alert reports submitted during the reporting interval] [an FDA Form 3500A for each adverse drug experience not reported as a post
marketing 15-day Alert report] [an index containing a line listing of your patient identification number and adverse reaction term(s)] [a history
of actions taken since the last report because of adverse drug experiences]. Specifically, ***

You, as a non-applicant, elected to submit to the applicant (rather than to FDA) all reports of adverse drug experiences that were both
serious and unexpected. However, you did not maintain complete records of these submissions, including [the date you received the
information] [a copy of each adverse drug experience report] [the date the report was submitted to the applicant] [the name and address of
the applicant]. Specifically, ***

You, as a non-applicant, elected to submit to the applicant (rather than to FDA) all reports of adverse drug experiences that were both
serious and unexpected. However, you did not submit each report to the applicant [within five calendar days of your receipt of the
information]. Specifically, ***

Initial post marketing 15-day Alert reports and follow-up reports have not been submitted under separate cover. Specifically, ***

Reports of serious adverse drug experiences were not submitted by a [packer] [distributor] to the manufacturer within 5 calendar days of
receipt of the report. Specifically, ***

Follow-up reports to post marketing 15-day Alert reports have not been submitted [within 15 calendar days of receipt of new information]
[upon request by FDA] . Specifically, ***

Serious, unexpected adverse drug experiences have not been [promptly] investigated. Specifically, ***

Each post marketing 15-day Alert report was not submitted to FDA within 15 calendar days of initial receipt of the information. Specifically,
***

Adverse drug experience information has not been reported to FDA. Specifically, ***

Records maintained of any modification of an established method employed in testing do not include [the reason for the modification] [the
data to verify that the modification produced results that are at least as accurate and reliable for the material being tested as the established
method]. Specifically, ***

The master production and control records indicate unjustified variations in the amount of components necessary for preparation of the
dosage form. Specifically, ***

The master production and control records do not include [the name and strength of the product] [a description of the dosage form].
Specifically, ***

Written procedures describing the handling of all written and oral complaints do not include provisions for review to determine whether the
complaint represents a serious and unexpected adverse drug experience which is required to be reported to the Food and Drug
Administration. Specifically, ***

Written complaint records do not include, where known, [the name and strength of the drug product] [lot number] [name of complainant]
[nature of complaint] [reply to complainant]. Specifically, ***

The written record or copy of the record of an investigation of a complaint conducted in relation to [any unexplained discrepancy] [ the failure
of a batch or any of its components to meet any of its specifications] is not maintained at the establishment where the investigation
occurred.
Batch production and control records do not include dates of each significant step in the [manufacture] [processing] [packing] [holding] of the
batch for each batch of drug product produced. Specifically, ***

Reserve samples for [active ingredients in OTC drug products] [OTC drug products] which are exempt from bearing an expiration date are
not retained for 3 years after the lot or batch of drug product is distributed. Specifically, ***

The reserve sample of drug product does not consist of at least twice the quantity necessary to perform all the required tests of drug
product. Specifically, ***

Samples taken of drug products for determination of conformance to written specifications are not [representative] [properly identified].
Specifically, ***

Samples taken of in-process materials for determination of conformance to specifications are not [representative] [properly identified].
Specifically, ***

Laboratory controls do not include a description of [sampling] [testing] procedures for in-process materials. Specifically, ***

Procedures designed to assure conformance to written specifications do not require appropriate retesting of [components] [drug product
containers] [closures] subject to deterioration. Specifically, ***

Written specifications for laboratory controls do not include a description of the [sampling] [testing] procedures used. Specifically, ***

Labeling or packaging materials which did not meet written specifications were not rejected to prevent their use in operations for which they
are unsuitable. Specifically, ***

Containers from which samples have been taken are not marked to show that samples have been taken from them. Specifically, ***

Components which must be sampled from top, middle and bottom of the container are not kept separate, but instead are composited for
testing. Specifically, ***

Returned drug products are not [identified as such] [held]. Specifically, ***

Reserve samples of active drug ingredients are deficient in that they are not retained at least one year after the expiration date of the last lot
of the drug containing the active drug ingredient. Specifically, ***

Test devices are deficient in that [instruments] [apparatus] [gauges] [recording devices] not meeting established specifications are used.
Specifically, ***

In-process samples are not [representative] [properly identified]. Specifically, ***

The specifications for in-process materials are deficient in that they do not include a description of the [sampling plan] [testing procedures]
for in-process materials. Specifically, ***

OTC products packaged for retail sale which are not specifically excluded from the requirement for tamper-evident packaging are not sold in
tamper-evident packages. Specifically, ***

The in-process control procedures are deficient regarding examination of dissolution time and rate. Specifically, ***

The in process control procedures were deficient in that they did not include an examination of the adequacy of mixing to assure uniformity
and homogeneity. Specifically, ***

Written procedures are lacking for the use of [rodenticides] [insecticides] [fungicides] [fumigating agents] [cleaning and sanitizing agents]
designed to prevent the contamination of [equipment] [components] [drug product containers] [closures] [packaging, labeling materials] [drug
products]. Specifically, ***

Washing and toilet facilities are not [provided] [easily accessible to working areas]. Specifically, ***

Adequate exhaust systems or other systems to control contaminants are lacking in areas where air contamination occurs during production.
Specifically, ***

Adequate ventilation is not provided. Specifically, ***

Adequate lighting is not provided in all areas. Specifically, ***

Complaint records are deficient in that they do not document the reason and the individual making the decision not to conduct a complaint
investigation. Specifically, ***

Complaint procedures are deficient in that written complaint records are not maintained in a file designated for drug product complaints.
Specifically, ***

Laboratory records are deficient in that they do not include the [initials] [signature] of the second person reviewing the record for accuracy.
Specifically, ***

Laboratory records are deficient in that they do not include the [initials] [signature] of the person performing the tests and the dates the tests
were performed. Specifically, ***

The master production and control record are deficient in that they do not include an accurate statement of [weight] [measure] of each
component, using the same weight system for each component. Specifically, ***

The master production and control records are deficient in that they do not include the [name] [weight] of each active ingredient per dosage
unit or unit of weight statement of total weight or measure of any dosage unit. Specifically, ***
No records are maintained for salvaged drug products. Specifically, ***

Drug products that have been subjected to improper storage conditions were salvaged and returned to the marketplace without further
evidence or inspection. Specifically, ***

The batch production and control records are deficient in that they do not include identification of persons [performing] [supervising]
[checking] each significant step in the operation. Specifically, ***

The batch production and control records are deficient in that they do not include documentation of the inspection of the [packaging]
[labeling] area before and after use. Specifically, ***

The batch production and control records are deficient in that they are not [an accurate reproduction of the appropriate master production or
control record] [checked for accuracy, dated, and signed]. Specifically, ***

Records do not include the disposition of rejected [components] [drug product containers] [closures] [labeling]. Specifically, ***

The entries in the equipment cleaning and use logs are not in chronological order. Specifically, ***

The evaluation of the stability of homeopathic drug products is not based on the same container-closure system in which the drug product
is being marketed. Specifically, ***

There are no written [standards or specifications] [methods of testing] [methods of cleaning] [methods of sterilization] [methods of
processing] to remove pyrogenic properties. Specifically, ***

Component testing is deficient in that each component is not tested for conformity with all appropriate written specifications for purity,
strength, and quality. Specifically, ***

Sampling procedures are deficient regarding sterile equipment and aseptic sampling techniques when sampling [components] [drug product
containers] [closures]. Specifically, ***

Drug product expiration dates are not related to the storage conditions stated on the labeling, as determined by stability studies.
Specifically, ***

There is a lack of rotation so that the oldest approved stock of [components] [drug product containers] [closures] is used first. Specifically,
***

There is insufficient physical or spatial separation from operations and other drug products to prevent mix-ups and cross-contamination.
Specifically, ***

Discrepancies found outside preset limits when reconciling the quantities of labeling issued, used and returned, were not [evaluated]
[investigated]. Specifically, ***
Records are not maintained for each shipment received of each different labeling and packaging material. Specifically, ***

Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions. Specifically,
***

Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the [room] [equipment] to produce aseptic
conditions. Specifically, ***

Aseptic processing areas are deficient in that [floors] [walls] [ceilings] are not smooth and/or hard surfaces that are easily cleanable.
Specifically,***

Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug
products. Specifically,***

Separate or defined areas to prevent contamination or mix-ups are deficient regarding laboratory controls and operations. Specifically, ***

Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the quarantine storage of drug
products prior to release. Specifically, ***

Written production and control procedures include batches formulated with the intent to provide less than 100 percent of the labeled or
established amount of active ingredient. Specifically, ***

Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the receipt, identification,
storage, and withholding from use of [components] [drug product containers] [closures] [labeling] pending sampling, testing, or examination
by the quality control unit before release for manufacturing or packaging. Specifically, ***

Procedures for the cleaning and maintenance of equipment are deficient regarding maintenance and cleaning schedules, including, where
appropriate, sanitizing schedules. Specifically, ***

The flow of [components] [drug product containers] [closures] [labeling] [in-process materials ] [drug products] though the building is not
designed to prevent contamination. Specifically, ***

Consultants lack sufficient education, training and experience to advise on the subject for which they are retained. Specifically, ***

Unauthorized personnel have access to enter areas of the buildings and facilities designated as limited access areas. Specifically, ***

Production personnel were not practicing good sanitation and health habits. Specifically, ***
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Center Name Cite Id Ref No Short Desc

Foods 905 21 CFR 123.6(b) HACCP plan implementation

1524 21 CFR 123.11(b) Sanitation monitoring

1560 21 CFR 110.35(c) Lack of effective pest exclusion

904 21 CFR 123.6(b) No HACCP plan

1525 21 CFR 123.11(c) Sanitation Records

12720 21 CFR 1.225 Not registered

945 21 CFR 123.12(a)(2) Importer verification

908 21 CFR 123.6(d) Signed and dated

6004 21 CFR 123.6(c)(4) Monitoring - adequacy

961 21 CFR 123.6(c)(3) Critical limits

6008 21 CFR 123.8(a)(3) Verification - record review -

frequency

960 21 CFR 123.6(c)(2) Critical control points

1422 21 CFR 110.20(b)(4) Floors, walls and ceilings

1552 21 CFR 110.35(a) Buildings/sanitary

6020 21 CFR 123.9(a) Records - content

963 21 CFR 123.6(c)(5) Corrective action plan

1553 21 CFR 110.35(a) Buildings/good repair

1306 21 CFR 110.20(b)(7) Screening

1287 21 CFR 110.20(a)(1) Harborage areas

6021 21 CFR 123.10 HACCP training or qualification

959 21 CFR 123.6(c)(1) Food safety hazards

1695 21 CFR 110.80(b)(2) Manufacturing conditions

933 21 CFR 123.8(a)(2)(ii) Calibration - adequacy

2386 21 CFR 110.80(a)(1) Storage

6001 21 CFR 123.11(b) Sanitation monitoring documentation

1554 21 CFR 110.35(a) Cleaning and sanitizing operations

1701 21 CFR 110.80(b)(7) Equipment, containers, utensils

1424 21 CFR 110.20(b)(4) Drip and condensate

1405 21 CFR 110.10(b)(6) Failure to wear

 990 21 CFR 110.10(b)(3) Not washed/sanitized when
appropriate

1007 21 CFR 110.10(b)(9) Precautions against contamination--

micro, foreign substances

1427 21 CFR 110.20(b)(5) Safety lighting and glass

6005 21 CFR 123.6(c)(6) Verification procedures - adequacy

1173 21 CFR 110.40(f) Q.C. instrument accuracy,

maintenance

1615 21 CFR 110.93 Storage/transportation of finished

goods (contamination)

6018 21 CFR 123.7(a) Corrective action per predetermined

plan

2392 21 CFR 110.80(b)(1) Maintenance of equip., utensils, and

finished food packaging

1689 21 CFR 110.80 Reasonable precautions

9930 21 CFR 120.6(c) SSOP records

3659 21 CFR 110.37(e)(3) Hand drying

1006 21 CFR 110.10(b)(8) Personal food/drink/tobacco

1556 21 CFR 110.35(b)(2) Storage requirements

931 21 CFR 123.8(d) Verification - recordkeeping

1562 21 CFR 110.35(d) Failure to clean - general

6015 21 CFR 123.6(c)(6) Verification procedures -
none/frequency

913 21 CFR 123.8(a)(1) Reassessment of HACCP plan

1292 21 CFR 110.20(b)(1) Sufficient space

1597 21 CFR 110.37(b)(3) As source of contamination

1581 21 CFR 110.37(e) Running water at suitable

temperature

1126 21 CFR 110.40(a) Precluding contaminants

6007 21 CFR 123.9(a) Records entries - timing

901 21 CFR 123.6(a) Hazard analysis

3661 21 CFR 110.37(e)(5) Signs

9941 21 CFR 120.8(a) No HACCP plan

906 21 CFR 123.6(b) HACCP plan location

1172 21 CFR 110.40(e) Lack of thermometer

6006 21 CFR 123.6(c)(7) Records values/observations

1125 21 CFR 110.40(a) Materials and workmanship

1402 21 CFR 110.10(b)(4) Unsecured jewelry

1696 21 CFR 110.80(b)(3) Holding foods -
refrigerate/freeze/heat

1599 21 CFR 110.37(b)(5) Backflow prevention

4470 21 CFR 108.25(c)(2) Process filing

9935 21 CFR 120.7(a) No hazard analysis

3652 21 CFR 110.37(e)(1) Suitable locations

1571 21 CFR 110.35(d)(5) Shown to be effective

3658 21 CFR 110.37(e)(2) Hand cleaning and sanitizing

preparations

6019 21 CFR 123.8(a)(2) Ongoing verification - complaints,

calibration records

9931 21 CFR 120.6(b) Sanitation monitoring

9958 21 CFR 120.12(c) Signed/dated

3654 21 CFR 110.37(d)(1) Maintained

985 21 CFR 110.10(b)(1) Suitable outer garments

6010 21 CFR 123.8(a)(3)(i) Monitoring record review adequacy

1406 21 CFR 110.10(b)(6) Effective use of hair restraint

1066 21 CFR 110.40(b) Seams on food contact surfaces

 1570 21 CFR 110.35(d)(5) Safe and adequate for use

1698 21 CFR 110.80(b)(5) Work-in-progress

1702 21 CFR 110.80(b)(8) Metal / extraneous materials

6022 21 CFR 123.12(c) Lack of records

950 21 CFR 123.12(d) Determination of compliance

1005 21 CFR 110.10(b)(7) Storage of personal items

12734 21 CFR 120.12(a) Required records not maintained

3080 21 CFR 114.83 Scheduled process establishment

6016 21 CFR 123.6(c)(7) Records system

1293 21 CFR 110.20(b)(2) Contamination with microorganisms,

chemicals, filth, etc.

1578 21 CFR 110.37(f) Odor, attractant for pests, harborage

3086 21 CFR 114.100(b) Maintenance of processing and

production records

9932 21 CFR 120.6(a) No SSOP or not implemented

12742 21 CFR 120.8(a) HACCP plan not implemented

932 21 CFR 123.7(d) Corrective action documentation

 1565 21 CFR 110.35(d)(3) Non-food-contact surfaces (S)

3085 21 CFR 114.100(a) Raw materials, packaging, finished

product

1403 21 CFR 110.10(b)(4) Hand jewelry - remove/cover

1426 21 CFR 110.20(b)(5) Adequate lighting

6014 21 CFR 123.6(c)(2) Monitoring - none

9955 21 CFR 120.11(a)(1) Verification activities

12749 21 CFR 120.8(b)(6) Verification procedures -

none/frequency

12755 21 CFR 120.11(a)(1) Records review signed

(iv)

1289 21 CFR 110.20(a)(3) Drainage

1709 21 CFR 110.80(b)(13) Filling, assembling, packing controls

9984 21 CFR 120.13(a) Training requirements

918 21 CFR 123.8(a) Verification - reviewers qualifications

1602 21 CFR 110.37(a) Suitable temp. and pressure

3656 21 CFR 110.37(d)(3) Self-closing doors

4479 21 CFR 108.25(e) Recall procedures

 1598 21 CFR 110.37(b)(4) Drainage

3643 21 CFR 110.10(b)(5) Glove condition

9928 21 CFR 120.12(b) General records requirements

12747 21 CFR 120.8(b)(3) Critical limits

1067 21 CFR 110.40(c) Non food-contact equipment in

processing area

1429 21 CFR 110.20(b)(6) Fans/air blowing equipment

6009 21 CFR 123.8(a)(3)(iii) Verification - record review -

calibration

4464 21 CFR 108.25(c)(1) Registration

9936 21 CFR 120.7(a) Hazard analysis - elements

3078 21 CFR 114.80(b) Code - required elements

6017 21 CFR 123.7(c) Corrective action per regulation

9934 21 CFR 120.6(a) SSOP does not address

9947 21 CFR 120.11(b) HACCP plan - failure to validate

12745 21 CFR 120.8(b)(1) Food hazards

975 21 CFR 123.9(b)(1) Record retention

 2393 21 CFR 110.80(b)(1) Teardown equipment/thorough
cleaning

3073 21 CFR 114.80(a)(2) pH testing

1128 21 CFR 110.40(a) Installation and maintenance of

equipment (S)

3071 21 CFR 114.80(a)(1) Scheduled process

3647 21 CFR 110.10(c) Training of handlers and supervisors

3663 21 CFR 110.40(e) Lack of automatic control / alarm (S)

12743 21 CFR 120.8(b)(4) Monitoring - adequacy

1184 21 CFR 110.35(e) Storage of cleaned portable

equipment (S)

1596 21 CFR 110.37(b)(2) Convey sewage

3062 21 CFR 114.10 Personnel

3712 21 CFR 110.93 Storage/transportation of finished

goods (deterioration)

9939 21 CFR 120.7(c) Consideration of hazards

9954 21 CFR 120.11(a)(1) Record review - CCP, CA

(iv)

12746 21 CFR 120.8(b)(2) Critical control points

1129 21 CFR 110.40(a) Food-contact - corrosion resistant

 1711 21 CFR 110.80(b)(15) Proper pH controls

2384 21 CFR 110.80(a)(7) Receipt/storage - liquid and dry raw

materials

2388 21 CFR 110.80(a)(5) Holding in bulk or suitable containers

3067 21 CFR 114.80(a) Quality control procedures

9943 21 CFR 120.8(a) Location and type

12750 21 CFR 120.8(b)(6) Validation procedures -

none/frequency

1601 21 CFR 110.37(a) Safe and adequate sanitary quality

2394 21 CFR 110.80(b)(6) Contamination by raw materials,

refuse, other ingredients

12751 21 CFR 120.8(b)(7) Recordkeeping system

929 21 CFR 123.8(b) Verification - corrective action

1566 21 CFR 110.35(d)(4) Single-service articles

1642 21 CFR 113.100(b) Review not signed/dated

3655 21 CFR 110.37(d)(2) Good repair

938 21 CFR 123.9(c) Official review

1090 21 CFR 110.40(d) Holding, conveying, mfg systems -

design & construction
 1561 21 CFR 110.35(c) Insecticides/rodenticides

1763 21 CFR 110.35(b)(1) Safe and adequate for use

1766 21 CFR 110.35(b)(1) Unacceptable toxic compounds

2361 21 CFR 110.80 Testing

9919 21 CFR 120.10(a) Steps to be taken

9957 21 CFR 120.12(a)(4) Records - HACCP system

9961 21 CFR 120.24(a) HACCP plan - microorganism

reduction

986 21 CFR 110.10(b)(2) Personal cleanliness

1425 21 CFR 110.20(b)(4) Spacing of equipment

3657 21 CFR 110.37(d)(4) Doors opening into processing areas

9929 21 CFR 120.12(b)(4) Recorded when observed

12744 21 CFR 120.8(b)(4) Monitoring - none

1697 21 CFR 110.80(b)(4) Preventive control measures

2385 21 CFR 110.80(a)(1) Inspection, segregation, handling of

raw materials

3090 21 CFR 114.100(d) Product distribution

1568 21 CFR 110.35(d)(2) Before use and after interruption

1641 21 CFR 113.100(b) Review not done/timely

3653 21 CFR 110.37(d) Readily accessible

3662 21 CFR 110.37(e)(6) Refuse receptacles

6002 21 CFR 123.11(b) Sanitation corrections

6012 21 CFR 123.8(a)(3)(iii) Calibration record review adequacy

899 21 CFR 123.16 Process controls

1643 21 CFR 113.100(c) Incomplete information

2396 21 CFR 110.80(b)(6) Conveyor transportation

3660 21 CFR 110.37(e)(4) Devices and fixtures

9926 21 CFR 120.14(a) Importer verification

9981 21 CFR 120.12(b)(4) Actual values

972 21 CFR 123.8(a)(1) Modification HACCP plan

1288 21 CFR 110.20(a)(2) Roads/yards/parking lots

2065 21 CFR 123.28(c) Shellstock records

 2275 21 CFR 129.80(g)(2) Chemical, physical, radiological

2391 21 CFR 110.80(a)(6) Thawed appropriately

3075 21 CFR 114.80(a)(4) Container testing

3082 21 CFR 114.89 Process deviation

3093 21 CFR 114.89 Process deviation evaluation - record

4296 21 CFR 110.80(a)(5) Temperature and humidity

4419 21 CFR 110.10(c) Level of competency (S)

9917 21 CFR 120.10(c) Corrective action documentation

9962 21 CFR 120.24(b) Direct treatment - not exempt under

120.24(b)

9964 21 CFR 120.25 Finished product not analyzed for

E.coli

12732 21 CFR 120.10(a) Corrective action - predetermined

plan

12754 21 CFR 120.11(a)(1) Calibration, testing - record review

(iv)(C)

1060 21 CFR 123.11(a) SSOP(S)

1176 21 CFR 110.40(f) Insufficient number of Q.C.

instruments

1196 21 CFR 110.10(a) Employees with illness, lesions,

contamination source
1330 21 CFR 113.100(a) Processing entry missing information

1577 21 CFR 110.37(f) Contamination of food, contact

surfaces, water supplies, etc

1734 21 CFR 113.40(a)(2) Corresponding with MIG

1751 21 CFR 113.40(a)(8) Size, fully open

2362 21 CFR 110.80 Reject and rework

2387 21 CFR 110.80(a)(1) Washing and cleaning

2389 21 CFR 110.80(a)(5) Identify rework

2848 21 CFR 113.40(g)(1)(i) Corresponding with MIG

(b)

3077 21 CFR 114.80(b) Visible code

3088 21 CFR 114.100(b) Processing and production - required

information

3089 21 CFR 114.100(c) Process deviations- identification and

records

3645 21 CFR 110.10(d) Supervision

3651 21 CFR 110.37(b)(5) Cross contamination

4062 21 CFR 113.100(a) Critical factors - entry missing

information

4181 21 CFR 113.89 Process deviation identification

 4421 21 CFR 110.20(a) Maintenance of grounds

4511 21 CFR 108.25(f) Approved school

4515 21 CFR 108.35(c)(2) Process filing

12709 21 CFR 129.80(c) Records of cleaning/sanitizing

solutions

12718 21 CFR 120.6(a) Before, during, after processing

12731 21 CFR 120.7(a)(2) Hazard evaluation not complete

976 21 CFR 123.9(b)(2) Process adequacy records

1132 21 CFR 110.40(a) Food-contact - unlawful indirect

additives

1255 21 CFR 129.20(a) Bottling room separation

1290 21 CFR 110.20(a)(4) Waste disposal

1534 21 CFR 113.100(b) Entries not done

1569 21 CFR 110.35(d)(2) Continuous operations

1600 21 CFR 110.37(a) General inadequacy

1669 21 CFR 110.80(a)(3) Aflatoxin and other natural toxins

1670 21 CFR 110.80(a)(4) Safety assurance - pests/extraneous

materials
 1706 21 CFR 110.80(b)(10) Mechanical manufacturing control

1812 21 CFR 129.80(c) Testing of cleaning/sanitizing

solutions

2301 21 CFR 129.80(f) Bacteriological contamination of

containers and closures (S)

2427 21 CFR 110.80(b)(9) Proper disposal of adulterated

product

3074 21 CFR 114.80(a)(2) Using pH meter

3650 21 CFR 110.35(d)(1) Wet cleaning

3709 21 CFR 110.80(a)(1) Inspection of containers and carriers

upon receipt

4295 21 CFR 110.40(a) Food contact - non-toxic materials

4465 21 CFR 114.100(c) Process deviations - action to rectify

4475 21 CFR 108.25(c)(3)(i) Process adherence

4476 21 CFR 108.25(c)(3)(ii) Process information availability

9952 21 CFR 120.11(a)(1)(i) Complaint review

12721 21 CFR 1.234 Registration not updated

12733 21 CFR 120.11(a)(1) Calibration, testing - record review

(iv)(C) timeliness

12748 21 CFR 120.8(b)(5) Corrective action plan

 939 21 CFR 123.9(f) Computerized records

949 21 CFR 123.12(c) Records, English

1130 21 CFR 110.40(a) Food-contact - withstand food &

cleaning cmpds.

1188 21 CFR 110.37(c) Sewage disposal

1487 21 CFR 113.87(b) Visual indicators not used

1500 21 CFR 113.89 Evaluation by process authority

1529 21 CFR 113.89 Process deviation log/file

1559 21 CFR 110.35(c) Guard/guide dogs

1595 21 CFR 110.37(b)(1) Sufficient quantities of water

1639 21 CFR 113.100(b) Entries not timely

1665 21 CFR 110.80(a)(2) Pasteurization or other adequate

treatment

1716 21 CFR 113.40(a)(11) Water valves, leakage

2274 21 CFR 129.80(g)(1) Bacteriological

2887 21 CFR 113.40(j) Conform to requirements

3068 21 CFR 114.80(a)(1) pH control

3708 21 CFR 110.80(a)(1) Water quality -- wash, rinse, convey
food

4178 21 CFR 113.83 Commercial production variations

4512 21 CFR 108.25(g) Record retention

4523 21 CFR 108.35(f) Recall procedures

4529 21 CFR 108.35(c)(2)(ii) Process change reporting to CFSAN

4530 21 CFR 114.100(c) Process deviations - product

disposition

9921 21 CFR 120.10(b) Corrective action - no plan

9937 21 CFR 120.7(b) Inside and outside hazards

9950 21 CFR 120.11(a) HACCP system not verified

9953 21 CFR 120.11(a)(1) CCP record review

(iv)(A)

9959 21 CFR 120.12(d)(1) Record retention

9963 21 CFR 120.24(c) Single facility - exempt process

9972 21 CFR 120.25(c) Analytical method

977 21 CFR 123.9(b)(3) Records stored at another location

1045 21 CFR 113.10 Supervisors

1093 21 CFR 110.40(g) Compressed air/gases

1197 21 CFR 110.10(a) Lack of instruction/reporting of health

conditions

1258 21 CFR 113.60(c) Coding - visible

1277 21 CFR 129.20(d) Enclosed room for container washing

and sanitizing

1303 21 CFR 113.81(f) Critical Factors

1317 21 CFR 113.87(d) Timing devices

1320 21 CFR 113.87(g) Bleeder mufflers

1325 21 CFR 113.100(e) Record retention

1329 21 CFR 113.100(a) Processing entries not done/not

timely

1331 21 CFR 113.100(a)(1) Still retorts

1334 21 CFR 113.100(a)(4) Aseptic processing

1353 21 CFR 129.35(a)(3)(i) Sampling for micro contaminants

1381 21 CFR 129.35(b) Free of oil, dust, rust, etc.

1412 21 CFR 129.37(b) Transport and storage

1472 21 CFR 113.83 Critical factors not stated

1486 21 CFR 113.87(b) System not established

1499 21 CFR 113.89 No corrective action taken

1533 21 CFR 113.100(b) RTC identification

1640 21 CFR 113.100(b) Entries not signed

1644 21 CFR 113.100(c) Not signed or initialed

1653 21 CFR 113.40(a)(1) Unreadable MIG thermometer

1688 21 CFR 110.80 Supervisory competence

1708 21 CFR 110.80(b)(12) Batters, breading, gravies, sauces,

etc.

1710 21 CFR 110.80(b)(14) Water activity controls

1735 21 CFR 113.40(a)(2) Unauthorized adjustment

1855 21 CFR 113.40(a)(12) Installation

1863 21 CFR 113.40(a)(12) Manifold header to atmosphere

1945 21 CFR 129.80(d) Records of sanitizing times and

intensities (S)

2056 21 CFR 123.28(a) HACCP plan

2057 21 CFR 123.28(c) Harvest licensure

2059 21 CFR 123.28(d) Labels - shucked shellfish

2067 21 CFR 123.28(d) Records - shucked shellfish

2101 21 CFR 113.40(a)(13) Measured, recorded

2271 21 CFR 129.80(e) Package identification

2272 21 CFR 129.80(e) Plant records

2320 21 CFR 113.40(c)(2) Corresponding with MIG

2332 21 CFR 113.40(c)(5) Location - separation

2342 21 CFR 113.40(c)(6) Heat distribution

2343 21 CFR 113.40(c)(7) Rotational speed

2369 21 CFR 129.80(a) Equipment / substances

2428 21 CFR 110.80(b)(9) Proper reconditioning

2503 21 CFR 113.40(e)(2) Unauthorized adjustment

2534 21 CFR 113.40(f)(2) Presence and accuracy

2820 21 CFR 113.40(g)(1)(i) Product-to-product regenerators

(d)

2860 21 CFR 113.40(g)(1)(i) Unauthorized speed changes

(f)
2869 21 CFR 113.40(g)(1)(ii) Readings at start of aseptic
(e) processing

2886 21 CFR 113.40(i) Inadequate instruments

3072 21 CFR 114.80(a)(1) Thermal processing

3091 21 CFR 114.100(e) Retention

3644 21 CFR 110.10(b)(5) Impermeable (S)

3648 21 CFR 110.20(a)(4) Neighboring grounds

3822 21 CFR 113.40(a)(1) Records of calibration (S)

3833 21 CFR 113.40(g)(1)(i) Barriers to product contamination (S)

(i)

3856 21 CFR 113.60(a) Visual

3866 21 CFR 113.60(a)(1)(i) Required can seam measurements

(a) (micrometer)

3874 21 CFR 113.60(b) Cooling water - failure to chlorinate,

etc.

3876 21 CFR 113.60(c) Coding - failure to mark

3877 21 CFR 113.60(c) Coding - required elements

3886 21 CFR 113.87(e) Clock time agreement with time of

day (S)

3887 21 CFR 113.89 Methods of process deviation

evaluation
4067 21 CFR 113.40(a)(12) Venting, other installations
(iii)

4460 21 CFR 114.80(a)(1) Use of preservatives (S)

4519 21 CFR 108.35(c)(3)(i) Process adherence

4520 21 CFR 108.35(c)(3)(ii) Process information availability

4521 21 CFR 108.35(d) Notify FDA - spoilage

4524 21 CFR 108.35(g) Approved school

6003 21 CFR 123.28(b) Harvest controls

6011 21 CFR 123.8(a)(3)(ii) Corrective action record review

adequacy

9812 21 CFR 106.100(k)(4) Complaint files

9914 21 CFR 120.14(c) Records, English

9923 21 CFR 120.10(b)(2) Review - trained individual

9933 21 CFR 120.6(b) Timely correction

9938 21 CFR 120.7(d) Sanitation evaluation not complete

(S)

9949 21 CFR 120.11(b) HACCP plan not modified

9975 21 CFR 120.25(d) Recording

 9986 21 CFR 120.24(c) Single facility - not exempt under
120.24(a)

12736 21 CFR 120.12(e) Official review

12737 21 CFR 120.14(a)(2)(i) Product specs

12753 21 CFR 120.11(a)(1) CA record review

(iv)(A)
Long Desc

You did not implement the [monitoring] [recordkeeping] [verification] procedures listed in your HACCP plan. Specifically, ***

You are not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with Current Good
Manufacturing Practices including [safety of water that comes into contact with food or food contact surfaces, including water used to
manufacture ice] [condition and cleanliness of food contact surfaces] [prevention of cross-contamination from insanitary objects]
[maintenance of hand washing, hand sanitizing, and toilet facilities] [protection of food, food packaging material, and food contact surfaces
from adulteration] [proper labeling, storage and use of toxic chemicals] [control of employee health conditions] [exclusion of pests].
Specifically,
Effective ***
measures are not being taken to [exclude pests from the processing areas] [protect against the contamination of food on the
premises by pests]. Specifically, ***

You do not have a written HACCP plan that outlines controls for a food safety hazard that is reasonably likely to occur. Specifically, ***

You are not maintaining sanitation control records that document [monitoring] [corrections of sanitation deficiencies] for [safety of water that
comes into contact with food or food contact surfaces, including water used to manufacture ice] [condition and cleanliness of food contact
surfaces] [prevention of cross-contamination from insanitary objects] [maintenance of hand washing, hand sanitizing, and toilet facilities]
[protection of food, food packaging material, and food contact surfaces from adulteration] [proper labeling, storage and use of toxic
chemicals] [control of employee health conditions] [exclusion of pests]. Specifically, ***
Your food facility is not registered as required. Specifically, ***

You do not have or have not implemented [written verification procedures] [product specifications] [an affirmative step] for ensuring that [fish]
[fishery products] you import are processed in compliance with the Seafood HACCP regulation. Specifically, ***

Your HACCP plan was not signed and dated [upon initial acceptance] [upon modification] [at least annually]. Specifically, ***

Your HACCP plan lists monitoring [procedures] [frequencies] that do not ensure compliance with the critical limit. Specifically***

Your HACCP plan [does not list a critical limit that ensures control of one or more hazards] [lists a critical limit that does not ensure control of
one or more hazards]. Specifically,

You did not review [some of] your [critical control point monitoring][corrective action][calibration][in-process testing][end-product testing]
records [within one week][within a reasonable time] after the records were made. Specifically, ***

Your HACCP plan does not list one or more critical control points that are necessary for each of the identified food safety hazards.
Specifically, ***

The plant is not constructed in such a manner as to allow [floors] [walls] [ceilings] to be [adequately cleaned and kept clean] [kept in good
repair]. Specifically, ***

Failure to maintain buildings, fixtures, or other physical facilities in a sanitary condition. Specifically, ***
Your records do not include the [name and location of the processor or importer] [date and time of the activity the record reflects] [signature
or initials of the person performing the operation] [identity of the product and the production code, if any]. Specifically, ***

Your HACCP plan includes a corrective action plan that is not in accordance with 21 CFR 123.7(b) to ensure [affected product is not entered
into commerce] [the cause of the deviation was corrected]. Specifically***

Failure to maintain [buildings] [fixtures] [physical facilities] in repair sufficient to prevent food from becoming adulterated. Specifically, ***

Failure to provide adequate screening or other protection against pests. Specifically, ***

Failure to [properly store equipment] [remove litter and waste] [cut weeds or grass] that may constitute an attractant, breeding place, or
harborage area for pests, within the immediate vicinity of the plant buildings or structures. Specifically, ***

No one associated with your firm has completed the required HACCP training or is HACCP qualified through job experience. Specifically, ***

Your HACCP plan does not list the food safety hazards that are reasonably likely to occur. Specifically, ***

Failure to [manufacture] [package] [store] foods under conditions and controls necessary to minimize [the potential for growth of
microorganisms] [contamination]. Specifically, ***

Your process monitoring equipment is not calibrated to ensure that it reads accurately. Specifically, ***

Failure to store raw materials in a manner that [protects against contamination] [minimizes deterioration]. Specifically, ***

Your sanitation control records do not accurately document the conditions or practices observed at your firm. Specifically***

Failure to conduct cleaning and sanitizing operations for utensils and equipment in a manner that protects against contamination of [food]
[food-contact surfaces] [food-packaging materials]. Specifically, ***

Failure to [construct] [handle] [maintain] equipment, containers and utensils used to [convey] [hold] [store] food in a manner that protects
against contamination. Specifically, ***

The plant is not constructed in such a manner as to prevent [drip] [condensate] from contaminating [food] [food-contact surfaces] [food-
packaging materials]. Specifically, ***

Failure to wear [hair nets] [head bands] [caps] [beard covers] [hair restraints] where appropriate. Specifically, ***
Employees did not [wash] [sanitize] hands thoroughly in an adequate hand-washing facility [before starting work] [after each absence from
the work station] [at any time their hands may have become soiled or contaminated]. Specifically, ***

Failure to take necessary precautions to protect against contamination of [food] [food contact surfaces] [food packaging systems] with
[microorganisms] [foreign substances]. Specifically, ***

Failure to provide safety-type [light bulbs] [lighting fixtures] [skylights] [glass] suspended over exposed food. Specifically, ***

Your HACCP plan lists verification [procedures] [frequencies] that have not been developed in accordance with 21 CFR 123.8(a) to ensure
that your HACCP plan is adequate to control food safety hazards, and is being effectively implemented. Specifically, ***

Instruments used for [measuring] [regulating] [recording] conditions that control or prevent the growth of undesirable microorganisms are not
[accurate] [adequately maintained]. Specifically,***

Failure to [store] [transport] finished food under conditions that would protect against [physical] [chemical] [microbial] contamination.
Specifically, ***

You did not take corrective action that ensured [affected product was not entered into commerce] [the cause of the deviation was corrected].
Specifically,***

Failure to maintain [equipment] [utensils] [finished food containers] in an acceptable condition through appropriate cleaning and sanitizing.
Specifically, ***

All reasonable precautions are not taken to ensure that production procedures do not contribute contamination from any source. Specifically,
***

You do not [always] maintain sanitation standard operating procedure records that document [the monitoring of conditions and practices
during processing] [corrections to conditions and practices that were not met]. Specifically, ***

Lack of a sanitary towel service or suitable hand drying devices. Specifically, ***

Employees were observed to be [eating food] [chewing gum] [drinking beverages] [using tobacco] in areas where [food is exposed]
[equipment or utensils are washed]. Specifically, ***

Failure to properly [identify] [hold] [store] toxic [cleaning compounds] [sanitizing agents] [pesticide chemicals] in a manner that protects
against contamination of [food] [food-contact surfaces] [food-packaging materials]. Specifically, ***

You do not maintain records of [calibration of process-monitoring instruments] [periodic end-product or in-process testing]. Specifically, ***

Failure to clean [food-contact surfaces] [utensils] as frequently as necessary to protect against contamination of food. Specifically, ***
Your HACCP plan does not list verification [procedures] [frequencies] that have been developed to ensure that the HACCP plan is adequate
to control food safety hazards, and is being effectively implemented. Specifically, ***

Your verification procedures do not include, at a minimum, reassessment of the HACCP plan [at least annually] [whenever modifications to
the process are made]. Specifically, ***

Failure to provide sufficient space for [placement of equipment] [storage of materials] as necessary for the maintenance of sanitary
operations and the production of safe food. Specifically, ***

Plumbing constitutes a source of contamination to [food] [water supplies] [equipment] [utensils]. Specifically, ***

Hand-washing facilities lack running water of a suitable temperature. Specifically, ***

The [design] [construction] [use] of equipment and utensils fails to preclude the adulteration of food with [lubricants] [fuel] [metal fragments]
[contaminated water] [contaminants]. Specifically, ***

Processing or other information was not [always] entered on your records at the time it was observed. Specifically, ***

You did not conduct, or have conducted for you, a hazard analysis to determine whether there are food safety hazards that are reasonably
likely to occur for each kind of fish and fishery product you process. Specifically, ***

Lack of posted, readily understandable signs directing employees to wash and sanitize hands as appropriate. Specifically, ***

You do not have a written HACCP plan that outlines controls for one or more food safety hazards that are reasonably likely to occur.
Specifically, ***

Your HACCP plan is not specific to [the location where the fish are processed] [the kind of fish or fishery product processed]. Specifically, ***

Lack of an accurate indicating thermometer, temperature measuring device, or temperature recording device in each freezer and cold
storage compartment used to store food capable of supporting the growth of microorganisms. Specifically, ***

Your monitoring records do not contain the actual values and observations obtained during monitoring. Specifically, ***

The [design] [materials] [workmanship] of [equipment] [utensils] does not allow proper [cleaning] [maintenance]. Specifically, ***

Employees failed to remove unsecured jewelry or other objects which might fall into [food] [equipment] [containers]. Specifically, ***
Failure to hold foods which can support the rapid growth of undesirable microorganisms at a temperature that prevents the food from
becoming adulterated. Specifically, ***

Lack of backflow protection from piping systems that discharge [waste water] [sewage]. Specifically, ***

Failure to provide the FDA, before packing any new product, information on the scheduled processes for each acidified food in each
container size. Specifically, ***

You did not develop, or have developed for you, a written hazard analysis to determine whether there are food hazards that are reasonably
likely to occur for [each type of] juice you produce. Specifically, ***
. Specifically, ***

Failure to provide [hand washing] [hand sanitizing] facilities at each location in the plant where needed. Specifically, ***

The [facility] [procedure] [machine] used for [cleaning] [sanitizing] of [equipment] [utensils] has not been shown to provide adequate
[cleaning] [sanitizing treatment]. Specifically, ***

Lack of effective hand [cleaning] [sanitizing] preparations. Specifically, ***

Your verification procedures do not include, at a minimum, ongoing verification activities including [review of consumer complaints]
[calibration of process monitoring instruments] [review of monitoring, corrective action, and calibration records]. Specifically, ***

You are not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with current good
manufacturing practice including [safety of water that comes into contact with food or food contact surfaces, including water used to
manufacture ice] [condition and cleanliness of food contact surfaces] [prevention of cross-contamination from insanitary objects]
[maintenance of hand washing, hand sanitizing, and toilet facilities] [protection of food, food packaging material, and food contact surfaces
from adulteration] [proper labeling, storage and use of toxic chemicals] [control of employee health conditions] [exclusion of pests].
Specifically,
Your [written***
hazard analysis] [written HACCP plan], required by the juice HACCP regulation, [was] [were] not signed and dated [upon initial
acceptance] [upon modification] [upon verification] [upon validation] [by the most responsible individual onsite at the processing facility or by
a higher level official]. Specifically, ***

Failure to maintain toilet facilities in a sanitary condition. Specifically, ***

Suitable outer garments are not worn that protect against contamination of [food] [food contact surfaces] [food packaging materials].
Specifically, ***

Your review of critical control point monitoring records does not [ensure that the records are complete] [verify that they document values that
are within critical limits]. Specifically, ***

Failure to wear [hair nets] [head bands] [caps] [beard covers] [appropriate hair restraints] in an effective manner. Specifically, ***

Failure to have smoothly bonded or well maintained seams on food contact surfaces, to minimize accumulation of [food particles] [dirt]
[organic matter] and the opportunity for growth of microorganisms. Specifically, ***
Sanitizing agents are [inadequate] [unsafe] under conditions of use. Specifically, ***

Failure to handle work-in-progress in a manner that protects against contamination. Specifically, ***

Failure to take effective measures to protect against the inclusion of [metal] [extraneous material] in food. Specifically, ***

You do not have records to document the performance and results of the affirmative steps taken to demonstrate that [fish] [fishery products]
imported into the United States were processed in accordance with the seafood HACCP regulation. Specifically, ***

You have not provided evidence that the [fish] [fishery products] you import have been processed under conditions that comply with the
Seafood HACCP regulation. Specifically, ***

Personal [clothing] [belongings] were stored in an area where [food is exposed] [equipment or utensils are washed]. Specifically, ***

You do not maintain [complete] records documenting [the implementation of your sanitation standard operating procedure] [your written
HACCP plan] [your written hazard analysis] [monitoring of critical control points and their critical limits] [corrective actions taken in response
to a deviation] [the verification of your HACCP system] [the validation of your HACCP plan] [the validation of your hazard analysis].
Specifically, ***

A scheduled process was not established by a qualified person who has expert knowledge acquired through appropriate training and
experience in acidification and processing of acidified foods. Specifically, ***

Your HACCP plan does not provide for a recordkeeping system that documents the monitoring of the critical control points. Specifically, ***

Proper precautions to protect [food] [food-contact surfaces] [food-packaging materials] from contamination with [microorganisms] [chemicals]
[filth] [extraneous material] cannot be taken because of deficiencies in plant [size] [construction] [design]. Specifically, ***

The [conveyance] [storage] [disposal] of [rubbish] [offal] does not minimize the [development of odor] [potential for waste becoming an
attractant and harborage or breeding place for pests]. Specifically, ***

Failure to maintain [processing] [production] records showing adherence to the scheduled processes, including records of [pH
measurement] [critical factors] intended to ensure a safe product. Specifically, ***

You do not [always] have or have not implemented a sanitation standard operating procedure that addresses sanitation conditions and
practices before, during and after processing. Specifically, ***

You did not [fully] implement the [monitoring] [validation] [verification] [recordkeeping] procedures listed in your HACCP plan. Specifically, ***

You do not have records that document corrective actions that were taken. Specifically, ***
Failure to clean non-food-contact surfaces of equipment as frequently as necessary to protect against contamination. Specifically, ***

Records are not maintained of the examination of [raw materials] [packaging materials] [finished products] [supplier's guarantees or
certificates] to verify compliance with FDA regulations and guidelines or action levels. Specifically, ***

Failure to [remove] [adequately cover] hand jewelry which cannot be adequately sanitized during periods where food is being manipulated
by hand. Specifically, ***

Failure to provide adequate lighting in [hand-washing areas] [dressing and locker rooms] [toilet rooms] [areas where food is examined,
stored, or processed] [areas where equipment and utensils are cleaned]. Specifically, ***

Your HACCP plan does not list the [procedures for monitoring] [frequency of monitoring] at each critical control point to ensure compliance
with the critical limit. Specifically,

Your verification activities do not include, at a minimum, [review of consumer complaints to determine whether they relate to the
performance of the HACCP plan] [calibration of process monitoring instruments] [end-product or in-product testing] [review of critical control
point monitoring, corrective action, and calibration records] to ensure that your HACCP system is being properly implemented. Specifically,
***

Your HACCP plan does not list the verification [procedures] [frequencies] that have been developed to ensure that the HACCP plan is being
implemented. Specifically, ***

Your review of [critical control point monitoring records] [corrective action records] [calibration records] [periodic end-product or in-process
testing records] are not [performed] [signed] [dated] by an individual who is trained in the application of HACCP principles to juice processing
or otherwise qualified through job experience. Specifically, ***

Lack of adequate drainage of areas which may contribute to contamination of food by [seepage] [foot-borne filth] [providing a breeding place
for pests]. Specifically, ***

Failure to perform [filling] [assembling] [packaging] in a manner that protects food from becoming contaminated. Specifically, ***

DO NOT CITE. See Notes for more information.

The [reassessment of your HACCP plan] [monitoring, corrective action, or verification record review] was not done by an individual who had
successfully completed training in the application of HACCP principles to fish and fishery product processing, or was otherwise qualified
through job experience to perform these functions. Specifically, ***

Failure to provide running water [at a suitable temperature] [under suitable pressure] for [processing of food] [cleaning of equipment, utensils
and food-packaging materials] [employee sanitary facilities]. Specifically, ***

Toilet facilities lack self-closing doors. Specifically, ***

Failure to prepare and maintain in files current procedures for [recalling products that may be injurious to health] [identifying, collecting,
warehousing and controlling products] [determining the effectiveness of recalls] [notifying FDA] [implementing recall programs]. Specifically,
***
Plumbing is not [of adequate size and design] [adequately installed and maintained] to provide adequate floor drainage. Specifically, ***

Gloves used in food handling are not maintained in an intact, clean, and sanitary condition. Specifically, ***

Your required records do not [always] include [the name of the processor] [the name of the importer] [the location of the processor] [the
location of the importer] [the date and time of the activity] [the signature or initials of the person performing the operation or creating the
record] [the identity of the product] [the production code]. Specifically, ***

Your HACCP plan [does not list one or more of the critical limits that must be met at each critical control point] [lists a critical limit that does
not prevent, eliminate, or reduce to an acceptable level the occurrence of an identified food hazard]. Specifically, ***

Non food-contact equipment in [manufacturing] [food handling] areas is not constructed so that it can be kept in a clean condition.
Specifically, ***

Failure to [locate] [operate] fans and other air-blowing equipment in a manner that minimizes the potential for contaminating [food] [food-
contact surfaces] [food-packaging materials]. Specifically, ***

You did not review [some of] your calibration records within a reasonable time after the records were made. Specifically, ***

Failure to register with the FDA information including the name, principal place of business and the location of the processing establishment
within 10 days after engaging in the manufacture, processing and packaging of acidified foods. Specifically, ***

Your written hazard analysis does not consist of [an identification of food hazards] [an evaluation of each food hazard identified to determine
if it must be addressed in the HACCP plan] [an identification of the control measures that can be applied] [a review of your current process
to determine whether modifications are necessary] [an identification of critical control points]. Specifically, ***

Each container is not marked with an identifying code specifying the [establishment where the product was packed] [product contained
therein] [year] [date] [packing period]. Specifically, ***

You did not take corrective action that ensured [the affected product was segregated] [a review of the affected product was done to
determine its acceptability] [affected product was not entered into commerce] [the cause of the deviation was corrected] [the HACCP plan
was reassessed in a timely manner to determine if modifications were needed to reduce the risk of reoccurrence of the deviation and
modified as necessary]. Specifically, ***

Your sanitation standard operating procedure does not address [the safety of the water that comes into contact with food or food contact
surfaces or that is used to manufacture ice] [the condition and cleanliness of food contact surfaces] [the prevention of cross-contamination
from insanitary objects] [the maintenance of hand washing, hand sanitizing, and toilet facilities] [the protection of food, food packaging
material, and food contact surfaces from adulteration with contaminants] [the proper labeling, storage, and use of toxic compounds] [the
control of employee health conditions that could result in microbiological contamination of the food, food packaging materials, and food
contact
You did surfaces] [the
not validate exclusion
that of pests
your HACCP from
plan the food plant].
is adequate Specifically,
to control *** [at least once within 12 months after implementation] [at least
food hazards
annually] [when a change in the process occurred that could have affected the hazard analysis or altered the HACCP plan in any way].
Specifically, ***

Your HACCP plan does not list all food hazards that are reasonably likely to occur. Specifically, ***

Your [monitoring] [corrective action] [verification] records are not maintained at your facility for at least the required time period. Specifically,
***
Failure to take apart equipment as necessary to ensure thorough cleaning. Specifically, ***

Failure to exercise sufficient control including [frequent testing] [recording of results] so that the finished equilibrium pH values are not higher
than 4.6. Specifically, ***

Failure to [install] [maintain] equipment so as to facilitate cleaning of [the equipment] [all adjacent spaces]. Specifically, ***

Acidified food is not manufactured in accordance with the scheduled process. Specifically, ***

Appropriate training in food handling techniques and food protection principles has not been provided to [food handlers] [supervisors].
Specifically, ***

Lack of [an automatic control for regulating temperature] [an automatic temperature alarm system] for each freezer and cold storage
compartment used to store food capable of supporting the growth of microorganisms. Specifically, ***

Your HACCP plan lists monitoring [procedures] [frequencies of performing procedures] that do not ensure compliance with the critical limits.
Specifically, ***

Failure to store cleaned and sanitized portable equipment in a [location] [manner] which protects food-contact surfaces from contamination.
Specifically, ***

Plumbing is not [of adequate size and design] [adequately installed and maintained] to properly convey sewage and liquid disposable waste
from the plant. Specifically, ***

Operators of processing and packaging systems are not under the operating supervision of a person who has attended and satisfactorily
completed a school approved by the Commissioner. Specifically, ***

Failure to [store] [transport] finished food under conditions that would protect against deterioration of the food and its container. Specifically,
***

In evaluating what food hazards are reasonably likely to occur, [you] [the person who performed the evaluation for you] did not consider
[microbiological contamination] [parasites] [chemical contamination] [unlawful pesticide residues] [decomposition] [natural toxins] [use of
unapproved color or food additives] [presence of undeclared ingredients that may be allergens] [physical hazards]. Specifically, ***

You did not review [all of] your [critical control point monitoring] [corrective action] records within one week (7 days) of the day the records
are made. Specifically, ***

Your HACCP plan does not list the critical control points for each of the identified food hazards. Specifically, ***

Lack of corrosion-resistant food contact surfaces. Specifically, ***

Failure to adequately [monitor pH] [maintain a pH of 4.6 or below] for foods that rely principally on the control of pH to prevent the growth of
undesirable microorganisms. Specifically, ***

Failure to receive and store [liquid] [dry] raw materials in bulk form in a manner which protects against contamination. Specifically, ***

Failure to hold [raw materials] [rework materials] [ingredients] in bulk or in suitable containers so as to protect against contamination.
Specifically, ***

Appropriate quality control procedures are not employed to ensure that finished foods do not present a health hazard. Specifically, "***

Your HACCP plan is not specific to [each location where juice is processed] [each type of juice processed]. Specifically, ***

Your HACCP plan does not list the validation [procedures] [frequencies] that have been developed to ensure that the HACCP plan is
adequate to control food hazards that are reasonably likely to occur. Specifically, ***

Failure to use water which is [safe] [of adequate sanitary quality] in food and on food-contact surfaces. Specifically, ***

Failure to take effective measures to protect finished food from contamination by [raw materials] [refuse] [other ingredients] . Specifically, ***

Your HACCP plan does not provide for a recordkeeping system that documents the monitoring of critical control points. Specifically, ***

You did not take immediate corrective action to ensure that [no affected product entered into commerce] [the cause of the deviation was
corrected] [the HACCP plan was reassessed] when your verification procedure revealed the need to take a corrective action. Specifically,
***

Failure to [store] [handle] [dispense] [use] [dispose of] single-service articles in a manner that protects against the contamination of food and
food-contact surfaces. Specifically, ***

Failure of the reviewer to [sign or initial] [date] the [processing records] [production records] [recording temperature chart(s)] after the
completion of the processing of a low-acid food product. Specifically, ***

Failure to keep toilet facilities in good repair. Specifically, ***

You did not make available for official review and copying at reasonable times [all records] [all plans and procedures] required by the
regulations. Specifically, ***

Lack of appropriate [design] [construction] to enable [holding] [conveying] [manufacturing] systems to be maintained in an appropriate
sanitary condition. Specifically, ***
Use of [insecticides] [rodenticides] without observing necessary precautions and restrictions to protect against contamination of [food] [food-
contact surfaces] [food-packaging materials]. Specifically, ***

Use of cleaning compounds and sanitizing agents which are not [free from undesirable microorganisms] [safe and adequate under the
conditions of use]. Specifically, ***

Storage or use of toxic materials which are not required to maintain clean and sanitary conditions, are unnecessary for use in laboratory
testing procedures, are unnecessary for plant and equipment maintenance, and are unnecessary for use in plant operations. Specifically,
***

Failure to perform [chemical] [microbial] [extraneous material] testing where necessary to identify [sanitation failures] [possible food
contamination]. Specifically, ***

You did not take corrective action that ensured [affected product was not entered into commerce] [the cause of the deviation was corrected].
Specifically, ***

The records you maintain to document the ongoing application of your HACCP plan do not include [the monitoring of critical control points
and their limits] [corrective actions]. Specifically, ***

Your HACCP plan does not include control measures that will consistently produce a 5 log reduction in the most resistant microorganism of
public health significance that is likely to occur in the juice, for a period at least as long as the shelf life of the product. Specifically, ***

Employees in contact with [food] [food-contact surfaces] [food-packaging materials] were not maintaining adequate personal cleanliness.
Specifically, ***

Aisles or working spaces between equipment and walls are [obstructed] [of inadequate width]. Specifically, ***

Toilet doors open into areas where food is exposed to airborne contamination, and there are no alternative means taken to prevent such
contamination. Specifically, ***

Processing and other information is not [always] entered on your records at the time it is observed. Specifically, ***

Your HACCP plan does not list the [procedures for monitoring] [frequency of monitoring] at each critical control point to ensure compliance
with the critical limits. Specifically, ***

Failure to use adequate [sterilization] [irradiation] [pasteurization] [freezing] [refrigeration] [pH control] [water activity control] to destroy or
prevent the growth of undesirable microorganisms in food. Specifically, ***

Failure to [inspect] [segregate] [handle] raw materials to ascertain that they are clean and suitable for processing into food. Specifically, ***

Records identifying initial distribution of finished product are not maintained. Specifically, ***
Failure to clean and sanitize food-contact surfaces in wet-processing [before use] [after any interruption during which they may have been
contaminated], to preclude contamination with microorganisms. Specifically, ***

A review of processing and production records by a qualified representative of plant management was not done [within one working day
after the completion of the process] [before shipment or release for distribution] to determine [completeness of the records] [whether
product was processed as specified by the scheduled process]. Specifically, ***

Failure to provide employees with [readily accessible] [adequate] toilet facilities. Specifically, ***

Refuse receptacles for hand washing facilities are not [constructed] [maintained] to protect against contamination of food. Specifically, ***

You did not correct sanitation deficiencies in a timely manner. Specifically,***

Your review of [calibration] [in-process testing][end-product testing] records does not ensure [that the records are complete] [that the
activities occurred in accordance with your written procedures] [occurred within a reasonable time after the records were made]. Specifically,
***

Your HACCP Plan for [smoked] [smoke flavored] fishery product does not include controls for Clostridium botulinum. Specifically, ***

Written records of all container closure examinations did not specify [product code] [date of container closure inspection] [time of container
closure inspection] [measurements obtained] [corrective actions taken]. Specifically, ***

Failure to take effective measures to protect food transported by conveyor from contamination. Specifically, ***

Devices and fixtures are not designed and constructed to protect against recontamination of clean, sanitized hands. Specifically, ***

You do not have written procedures that describe [product specifications] [affirmative steps] to ensure that juice you receive for import into
the United States was processed in accordance with the juice HACCP regulation. Specifically, ***

Your records do not [always] contain the actual values and observations obtained during monitoring. Specifically, ***

You did not immediately modify your HACCP plan after a reassessment revealed the plan to no longer be adequate. Specifically, ***

Failure to properly maintain [roads] [yards] [parking lots] so that they do not constitute a source of contamination in areas where food is
exposed. Specifically, ***

You do not maintain records that document the [date of harvest] [location of harvest by State and site] [quantity and type of shellfish
received] [date of receipt] [name of the harvester OR registration number of the harvester vessel OR the identification number of the
harvester issued by the shellfish control authority]. Specifically, ***
You do not take and analyze samples of bottled drinking water for [chemical] [physical] [radiological] testing at least annually [for each type
of bottled drinking water produced during a day's production run]. Specifically, ***

Failure to thaw frozen raw materials in a manner that prevents them and other ingredients from becoming adulterated. Specifically, ***

Failure to [test] [examine] containers often enough to ensure that containers suitably protect the food from leakage and contamination.
Specifically, ***

Failure to fully reprocess, thermally process as a low-acid food under 21 CFR 113, or set aside for further evaluation as to any potential
public health significance, a portion of food which [deviated from a scheduled process] [had an equilibrium pH of the finished product higher
than 4.6]. Specifically, ***

Failure to record the [procedures used in the evaluation of process deviations] [results of process deviation evaluations]. Specifically, ***

Failure to hold [raw materials] [rework materials] [ingredients] at proper temperature and humidity to prevent the food from becoming
adulterated. Specifically, ***

Personnel responsible for identifying [sanitation failures] [food contamination] lack a background of education and experience to provide a
needed level of competency. Specifically, ***

You do not have records that [fully] document corrective actions that were taken. Specifically, ***

Your treatments intended to achieve a 5-log reduction in the most resistant microorganism of public health significance are not applied
directly to the juice, and the exemption for surface treatment of fruit does not apply. Specifically, ***

You do not [always] analyze your finished juice product for biotype I Escherichia coli. Specifically, ***

Your HACCP plan includes a corrective action plan. There was a deviation from a critical limit and you did not take corrective action that
ensured [product that was injurious to health or otherwise adulterated did not enter commerce] [the cause of the deviation was corrected].
Specifically, ***

Your review of [calibration of process monitoring instruments] [periodic end-product testing] [periodic in-process testing] records does not
ensure that [the records are complete] [the activities occurred in accordance with your written procedures]. Specifically, ***

You [do not have] [have not implemented] a written sanitation standard operating procedure (SSOP). Specifically, ***

An inadequate number of instruments used for [measuring] [regulating] [recording] conditions that control or prevent the growth of
undesirable microorganisms. Specifically,***

Employees who appear to have an [illness] [open lesion] [abnormal source of microbial contamination] are not excluded from operations
where there is a reasonable possibility of [food] [food contact surfaces] [food packaging materials] becoming contaminated. Specifically, ***
Forms used to record processing or production information lack the [product] [code number] [date] [retort or processing system number]
[container size] [approximate number of containers per coding interval] [initial temperature] [actual processing time] [mercury-in-glass
thermometer readings] [recording thermometer readings] [appropriate processing data]. Specifically, ***

The [conveyance] [storage] [disposal] of [rubbish] [offal] does not protect against contamination of [food] [food-contact surfaces] [water
supplies] [ground surfaces]. Specifically, ***

Failure to properly adjust the temperature-recording device. The temperature recorded on the temperature-recording device chart [was
higher than] [did not agree with] the mercury-in-glass thermometer during processing. Specifically, ***

Bleeders were [smaller than 1/8-inch] [not wide open during the entire process] [not open during come-up-time]. Specifically, ***

Food which has become contaminated to the extent of being adulterated within the meaning of the Act is not rejected or if permissible,
treated or processed to eliminate the contamination.. Specifically, ***

Failure to adequately [wash] [clean] raw materials as necessary to remove soil or other contamination. Specifically, ***

Failure to identify material scheduled for rework as such. Specifically, ***

Failure to properly adjust the temperature-recording device. The temperature recorded on the temperature-recording device chart [was
higher than] [did not agree with] a known accurate mercury-in-glass thermometer. Specifically, ***

Each container is not marked with an identifying code permanently visible to the naked eye. Specifically, ***

The [processing] [production] records do not contain sufficient additional information such as [product code] [date] [container size] [product]
to permit a public health hazard evaluation of the processes applied to each [lot] [batch] [portion] of production. Specifically, ***

Departures from a scheduled process having a possible bearing on public health or the safety of a food are not [noted] [identified] [recorded]
[made the subject of a separate file (or log identifying the appropriate data) delineating them]. Specifically, ***

Responsibility for assuring compliance with current good manufacturing practices relating to personnel has not been assigned to competent
supervisory personnel. Specifically, ***

Systems that discharge waste water or sewage are cross-connected to systems that carry water for food or food manufacturing.
Specifically, ***

Forms used to record critical factors lack [closing machine vacuum in vacuum-packed products] [maximum fill-in weight] [drained weight]
[critical factors specified in the scheduled process]. Specifically, ***

Failure to identify, from processor check or otherwise, deviations from the scheduled process or critical factors which are out of control.
Specifically, ***
Maintenance of the grounds is inadequate to protect against contamination of food. Specifically, ***

Failure to have personnel involved in [acidification] [pH control] [heat treatment] [critical factors] under the operating supervision of a person
who has attended and satisfactorily completed a school approved by the Commissioner. Specifically, ***

Failure to provide FDA, before packing any new product, information as to the scheduled process for each low-acid canned food in each
container. Specifically, ***

You do not maintain records of [sampling] [testing] of cleaning and sanitizing solutions. Specifically, ***

Your sanitation standard operating procedure does not address sanitation conditions and practices [before] [during] [after] processing.
Specifically, ***

The evaluation of a food hazard identified in your written hazard analysis [did not determine if the hazard were reasonably likely to occur]
[did not include an assessment of the severity of the illness or injury if the food hazard occurred]. Specifically, ***

The records that relate to the general adequacy of your [processes] [equipment] were not maintained for at least two years after their
applicability to the product you produced. Specifically, ***

Failure to maintain food contact surfaces to protect food from contamination by any source, including unlawful indirect food additives.
Specifically, ***

The bottling room is not [adequately] separated from other plant operations or storage areas, so as to protect against contamination.
Specifically, ***

Failure to properly maintain operating systems for waste treatment and disposal so that they do not constitute a source of contamination in
areas where food is exposed. Specifically, ***

Required entries on [processing records] [production records] were not made by the retort or processing system operator or other
designated person for specific retort operations or conditions specified in the scheduled process. Specifically, ***

Failure to clean and sanitize utensils and food-contact surfaces of equipment in continuous wet-processing operations as necessary.
Specifically, ***

Failure to use a water supply that is [sufficient for the operations] [derived from an adequate source]. Specifically, ***

There is no assurance that [raw materials] [ingredients] which are susceptible to contamination with aflatoxin or other natural toxins comply
with current FDA standards before being incorporated into food. Specifically, ***

There is no assurance that [raw materials] [ingredients] [rework materials] which are susceptible to contamination with [pests] [undesirable
microorganisms] [extraneous materials] comply with current FDA standards and defect action levels. Specifically, ***
Failure to perform mechanical manufacturing steps so as to protect food against contamination. Specifically, ***

You do not [sample] [test] cleaning and sanitizing solutions [as often as necessary] to assure adequate performance. Specifically, ***

You do not take a bacteriological swab and/or rinse count at least every three months from at least four containers and closures selected
just prior to filling and sealing. Specifically, ***

Failure to dispose of adulterated [food] [raw materials] in a manner which protects against the contamination of other food. Specifically, ***

Failure to [use a potentiometer to measure pH] [relate in-process measurements by titration or colorimetry to the finished equilibrium pH]
when the finished equilibrium pH is above 4.0. Specifically, ***

Failure to sanitize and thoroughly dry, prior to use, food-contact surfaces which have been wet cleaned. Specifically, ***

Failure to inspect [containers] [carriers] of raw materials upon receipt to ensure that their condition does not contribute to the contamination
or deterioration of food. Specifically, ***

Food-contact surfaces are not made of non-toxic materials. Specifically, ***

Failure to record the action taken to rectify a departure from a scheduled process. Specifically, ***

Failure to process each food in conformity with at least the scheduled process filed with FDA. Specifically, ***

Failure to provide the FDA, after written request, any process and procedure information deemed necessary to determine the adequacy of
the process. Specifically, ***

Your review of consumer complaints does not determine whether such complaints [relate to the performance of the HACCP plan] [reveal
previously unidentified critical control points]. Specifically, ***

You did not submit an update to your facility's registration within 60 calendar days of [a change] [changes] to the registration information
previously submitted. Specifically, ***

You did not review [all of] your [calibration] [periodic end-product testing] [in-process testing] records within a reasonable time after the
records were made. Specifically, ***

Your HACCP plan includes a corrective action plan that is not in accordance with 21 CFR 120.10(a) to ensure [affected product is not
entered into commerce] [the cause of the deviation was corrected]. Specifically,***
Your computerized records do not provide that appropriate controls are implemented to ensure the integrity of the electronic data and
signatures. Specifically, ***

The records that document the performance and results of the affirmative step you chose are not in English. Specifically, ***

Food contact surfaces are not designed to [withstand the environment of their intended use] [withstand the action of food] [withstand
cleaning compounds and sanitizing agents]. Specifically, ***

Failure to dispose of sewage into an adequate sewerage system or by other adequate means. Specifically, ***

Heat-sensitive indicators or other means are not used to visually show that a thermal process has been applied to containers in a retort
basket, truck, car, or crate used to hold containers in a retort. Specifically, ***

Failure to have a deviation from the scheduled process evaluated for public health significance by a competent processing authority.
Specifically, ***

Process deviations were not recorded in a separate file or log that details both the deviations and the actions taken. Specifically, ***

The [guard dog] [guard dogs] [guide dog] [guide dogs] in the plant are likely to result in the contamination of [food] [food-contact surfaces]
[food-packaging materials]. Specifically, ***

Plumbing is not [of adequate size and design] [adequately installed and maintained] to carry sufficient quantities of water to required
locations throughout the plant. Specifically, ***

Entries on [processing records] [production records] were not made at the time the specific retort or processing system condition or
operation occurred. Specifically, ***

[Raw materials] [Ingredients] which contain levels of microorganisms that may produce food poisoning or other disease are not pasteurized
or otherwise adequately treated. Specifically, ***

Failure to supply a suitable water valve used for water cooling to prevent leakage of water into the retort during processing. Specifically, ***

You do not take and analyze samples of bottled drinking water for bacteriological testing at least once a week [for each type of bottled
drinking water produced during a day's production run]. Specifically, ***

The system, equipment, and procedures used for thermal processing of foods in hermetically sealed containers [did not conform to the
applicable requirements of 21 CFR 113.40] [did not conform to methods and controls specified in the scheduled process] [were not operated
and administered in a manner that ensures commercial sterility is achieved]. Specifically, ***

Acidified foods are not manufactured, processed and packaged to [achieve within the time designated in the scheduled process] [maintain]
a pH value of 4.6 or lower in all finished foods. Specifically, ***
Water [used] [re-used] to [wash] [rinse] [convey] food is not [safe] [of adequate sanitary quality]. Specifically, ***

Failure to provide for the type, range, and combination of variations encountered in commercial production in establishing the scheduled
process. Specifically, ***

Failure to prepare, review and retain at [the processing plant] [a reasonably accessible location] for three years all records [of processing] [of
deviations in processing] [specified in 21 CFR 114]. Specifically, ***

Failure to prepare and maintain in files current procedures for [recalling products which may be injurious to health] [identifying, collecting,
warehousing and controlling products] [determining effectiveness of recalls] [notifying FDA] [implementing recall programs]. Specifically, ***

For an intentional change in a previously filed scheduled process, failure to submit to CFSAN, within 30 days after first use, [a complete
description of the modifications made and utilized] [a copy of the file record showing prior substantiation by a qualified scientific authority as
to the safety of the changed process]. Specifically, ***

Failure to record the disposition of product involved in a departure from a scheduled process. Specifically, ***

Your HACCP plan does not include a corrective action plan. There was a deviation from a critical limit and you did not take corrective action
that ensured [affected product was segregated and held] [a review of the affected product by someone who is adequately trained or
experienced was done to determine its acceptability] [product that was injurious to health or otherwise adulterated was not entered into
commerce] [the cause of the deviation was corrected] [the HACCP plan was verified by someone meeting the training requirements of the
regulation to determine if modifications were needed to reduce the risk of recurrence of the deviation and to modify the HACCP plan as
necessary].
Your Specifically,
hazard analysis does ***not include food hazards that can be introduced [within] [outside] the processing plant environment. Specifically,
***

You do not verify that your HACCP system is being implemented according to design. Specifically, ***

Your review of critical control point monitoring records does not [ensure that the records are complete] [verify that they document values that
are within critical limits]. Specifically, ***

You do not retain [all of] the required records at your facility for the required time period. Specifically, ***

You do not process and perform final product packaging in a single facility operating under current good manufacturing practices.
Specifically, ***

You do not [always] analyze each juice subsample for the presence of Escherichia coli by the official method or another method that is at
least equivalent. Specifically, ***

You did not immediately return your records for official review upon demand. Specifically, ***

Supervisors have not satisfactorily completed training in a school approved by the Commissioner for areas under their responsibility.
Specifically, ***
Failure to ensure that compressed air or other gases [mechanically introduced into food] [used to clean food-contact surfaces or equipment]
have been treated in such a way that foods are not contaminated with unlawful indirect food additives. Specifically, ***

Personnel with adverse health conditions are not instructed to report to their supervisors. Specifically, ***

Hermetically sealed containers do not have an identifying code permanently visible to the naked eye. Specifically ***

You do not [wash] [sanitize] containers for bottled drinking water in an enclosed room. Specifically, ***

The critical factors identified in the schedule process for the prevention of the growth of microorganisms not destroyed by the thermal
process are not controlled in a manner to ensure the limits established are not exceeded. Specifically, ***

Failure to provide accurate timing devices to ensure that the processing and venting times specified in the scheduled process are achieved.
Specifically, ***

Failure to keep on file evidence that mufflers on [bleeders] [the vent system] are operating in a manner that does not impede the removal of
air . Specifically, ***

Copies of processing, production, and other required records for each lot of a low-acid food processed were not retained at the processing
plant [for a one year period following manufacture] [or other reasonably accessible location for a total of a three-year record-retention
period]. Specifically, ***

Required information was not entered on designated forms at the time the observation was made by the retort or processing system
operator or designated person. Specifically, ***

Forms used in recording specific processing and production information for still retorts lack [the time that steam was turned on] [the time that
the retort reached processing temperature] [the time that steam was shut off] [venting time] [venting temperature]. Specifically, ***

Forms used in recording specific processing and production information for aseptic processing and packaging systems lack [the product
temperature in the holding tube outlet] [the product temperature in the final heater outlet] [differential pressure] [product flow rate]
[sterilization media flow rate] [sterilization media temperature] [retention time of containers and closures] [sterilization cycle times]
[sterilization cycle temperatures]. Specifically, ***

The [product] [operations] source water that is obtained from other than a public water system is not sampled and analyzed for
microbiological contaminants at least once each week. Specifically, ***

Air under pressure that is directed at [product water] [a product water-contact surface] is not free of [oil] [dust] [rust] [excessive moisture]
[extraneous materials]. Specifically, ***

After cleaning, you do not [transport] [store] all [multiservice containers] [utensils] [disassembled piping and equipment] in such a manner as
to [assure drainage] [be protected from contamination]. Specifically, ***

Critical factors that may affect the scheduled process are not specified in the scheduled process. Specifically, ***
A system of traffic control to prevent unretorted product from bypassing the retort system has not been established. Specifically, ***

No corrective action was taken, e.g. fully reprocessing or setting the lot aside for evaluation, when a deviation from the scheduled process
was found. Specifically, ***

Recording thermometer charts were not identified by [date] [retort number] [data to correlate with written records of lots processed].
Specifically ***

The retort or processing system operator or other designated person did not initial or sign each record form. Specifically, ***

Written records of container closure examinations were not signed or initialed by the container closure inspector. Specifically, ***

Mercury-in-glass thermometers were not installed where they can be accurately and easily read. Specifically, ***

The function of supervising overall sanitation of the plant has not been designated to the supervision of one or more competent individuals
assigned responsibility for this function. Specifically, ***

Failure to treat and maintain [batters] [breading] [sauces] [gravies] [dressings and similar preparations] in a manner that protects against
[contamination] [growth of microorganisms]. Specifically, ***

Failure to adequately [process to] [maintain at] a safe moisture level foods that rely on the control of water activity to prevent the growth of
undesirable microorganisms. Specifically, ***

There was no means to prevent unauthorized changes in adjustment to the temperature-recording device. Specifically, ***

Vents are not installed so as to provide complete removal of air from a retort before the process start time. Specifically, ***

A manifold header connecting vents or manifolds from several retorts was not vented to the atmosphere. Specifically, ***

You do not maintain [adequate] records regarding [the intensity of the sanitizing agent] [the time duration that the sanitizing agent was in
contact with the surface being sanitized]. Specifically, ***

Your HACCP plan for raw molluscan shellfish does not include controls to ensure the molluscan shellfish are harvested from an approved
source. Specifically, ***

You do not have controls to ensure that the shellstock you receive [is from a harvester that is in compliance with licensure requirements or
from a processor certified by a shellfish control authority] [has a tag affixed to each container or is accompanied by a bill of lading or similar
document with specific information]. Specifically, ***
You do not have controls in place to ensure that shucked molluscan shellfish are in containers that bear a label that discloses [the date and
place they were harvested] [the type and quantity of shellfish] [by whom they were harvested]. Specifically, ***

You do not maintain records of shucked molluscan shellfish that document the [date of receipt] [quantity and type of shellfish] [name and
certification number of the packer or repacker of the product]. Specifically, ***

Critical factors are not [measured] [recorded] on the processing record at intervals of sufficient frequency to ensure that the factors are within
limits specified in the scheduled process. Specifically, ***

You do not identify each unit package from a [batch] [segment of a continuous production run] of bottled drinking water with a production
code which identifies [the particular batch] [the segment of production run] [the day produced]. Specifically, ***

You do not record and maintain information as to the [kind of product] [volume produced] [date produced] [lot code used] [distribution of
finished product to wholesale and retail outlets]. Specifically, ***

Failure to properly adjust the temperature-recording device. The temperature recorded on the temperature-recording device chart [was
higher than] [did not agree with] the mercury-in-glass thermometer during processing. Specifically, ***

Retort bleeders are installed more than eight (8) feet apart. Specifically, ***

Heat distribution data or documentary proof from the retort manufacturer or process authority that adequate venting is achieved in the retort
was not kept on file. Specifically, ***

The rotational speed of the retort was not [specified in the scheduled process] [adjusted and recorded when the retort is started] [adjusted
and recorded when a speed change was made] [adjusted and recorded at intervals of sufficient frequency to ensure the speed was
maintained as specified in the scheduled process]. Specifically, ***

You treat product water [in and by equipment] [with substances] that may adulterate the bottled product. Specifically, ***

Failure to use a proven effective method of reconditioning adulterated food. Specifically, ***

There was no means of preventing unauthorized changes in adjustment to the temperature-recording device. Specifically, ***

Each retort did not have an accurate temperature-recording device. Specifically, ***

The product-to-product regenerator was not [designed] [operated] [controlled] to ensure that the pressure of the sterilized product in the
regenerator is greater than that of the unsterilized product in the regenerator. Specifically, ***

There was no means of preventing unauthorized speed changes to the metering pump. Specifically, ***
Measurements or observations of the [temperature-indicating device in the holding tube outlet] [temperature recorder in the holding tube
outlet] [temperature recorder-controller at the final heater outlet] [differential pressure recorder-controller] [product flow rate] [sterile air
pressure] [proper performance of seam seals or similar devices] were not [performed] [recorded] at the start of aseptic processing to ensure
the values were as specified in the scheduled process for aseptic packaging operations. Specifically, ***

The time and temperature of processing and other critical factors specified in the scheduled process were not measured with instruments
having adequate accuracy or dependability. Specifically, ***

Acidified foods are not thermally processed to an extent that is sufficient to destroy the vegetative cells of microorganisms of public health
significance and those of nonhealth significance capable of growing in the food. Specifically, ***

Required records are not maintained at the processing plant or other reasonably accessible location for a period of three years from the
date of manufacture. Specifically, ***

Gloves used for food handling are not impermeable. Specifically, ***

Failure to take adequate care to exclude contamination of food from adverse conditions on bordering grounds not under your control.
Specifically, ***

Failure to maintain records of accuracy checks of temperature-indicating devices specifying [date] [standard used] [method used] [person
performing the test]. Specifically, ***

Failure to supply steam seals or other effective barriers at potential access points to the product downstream from the product-sterilizing
holding tube. Specifically, ***

Failure of the operator, closure supervisor, or other qualified person to visually examine [the top seam of a can randomly selected from each
seaming head] [the closure of a typical container]. Specifically ***

Records of the results of micrometer measurements of double seam cans fail to include [cover hook] [body hook] [width] [tightness]
[thickness]. Specifically, ***

Failure to chlorinate or otherwise sanitize container cooling water as necessary for cooling canals and recirculated water supplies.
Specifically, ***

Failure to mark each hermetically sealed container of low-acid processed food with an identifying code that is permanently visible to the
naked eye. Specifically, ***

The required container identification fails to include the [establishment where packed] [product] [year packed] [day packed] [period during
which packed]. Specifically, ***

Failure of the clock times indicated on recording-temperature charts to reasonably correspond to the time of day on the written processing
records. Specifically, ***

Failure to use procedures recognized by competent processing authorities as being adequate to detect any potential hazard to public health
in the evaluation of a deviation from the scheduled process. Specifically, ***
Failure to have heat distribution data on file which demonstrates that adequate venting of air is accomplished, for retort installations which
deviate from the diagrams in [113.40(a)(12)(i)(a)] [113.40(a)(12)(i)(b)] [113.40(a)(12)(i)(c)] [113.40(a)(12)(i)(d)] [113.40(a)(12)(ii)(a)]
[113.40(a)(12)(ii)(b)]. Specifically, ***

Failure to use preservatives (in lieu of thermal processing) to inhibit reproduction of microorganisms of non-health significance. Specifically,
***

Failure to process each low-acid canned food in conformity with at least the scheduled process. Specifically, ***

Failure to provide FDA, when requested in writing, with information concerning processes and procedures deemed necessary to determine
the adequacy of the process. Specifically, ***

Failure to notify FDA about [spoilage] [process deviations] of potential public health significance when all or part of a lot was distributed.
Specifically, ***

Failure to have personnel involved in [retorts] [thermal processing systems] [aseptic processing and packaging systems] [thermal processing
systems] [container closure inspections] under the operating supervision of a person who has attended and satisfactorily completed a school
approved by the Commissioner. Specifically, ***

You do not ensure that raw molluscan shellfish being processed are obtained from growing waters approved for harvesting by a shellfish
control authority. Specifically***

Your review of corrective action records does not [ensure that the records are complete] [verify that the appropriate corrective actions have
been taken]. Specifically, ***

Failure to maintain complaint files [in two separate classes, e.g., complaints that allege that an infant became ill from consuming the product,
or that an infant required treatment by a physician or health-care provider; and complaints that may involve a possible existence of a hazard
to health, but do not indicate that an infant became ill or required treatment]. Specifically, ***

You do not have records [in English] that document the performance and results of the affirmative steps you chose. Specifically, ***

Your review to determine the acceptability of affected product for distribution when a deviation from a critical limit occurred was not
performed by [an individual] [individuals] with adequate training or experience . Specifically, ***

You do not [always] correct deficiencies from good manufacturing practice in a timely manner. Specifically, ***

You did not evaluate [product ingredients] [processing procedures] [packaging] [storage] [intended use] [facility and equipment function and
design] [plant sanitation, including employee hygiene] to determine the potential effect on the safety of the finished food for the intended
consumer. Specifically, ***

You did not immediately modify your HACCP plan after a validation revealed that the plan was no longer adequate. Specifically, ***

You did not [always] record positive results for Escherichia coli analysis. Specifically, ***
You do not conduct the 5-log reduction process and perform final packaging of your juice within a single production facility operating under
current good manufacturing practices. Specifically, ***

You did not make all required records available for review and copying at reasonable times. Specifically, ***

Your product specifications are not designed to ensure that imported juice [is safe] [has been processed under sanitary conditions].
Specifically, ***

Your review of corrective action records does not [ensure that the records are complete] [verify that the appropriate corrective actions were
taken]. Specifically, ***
Frqncy

364

323

263

258

250

249

238

210

204

195

186

165

145

140
139

136

135

131

119

119

117

113

110

101

98

95

94

92

89
84

83

81

76

75

74

74

73

72

72

70

67

67

66

66
64

58

58

58

55

54

52

51

51

51

50

50

49

48

48
46

45

44

44

43

42

42

42

42

42

41

40

40

39

37
36

36

36

36

35

35

35

33

33

32

32

32

32

32

31
29

29

28

28

26

26

26

26

25

25

25

23

23

23

23
22

22

22

22

21

20

20

19

19

18

18

18

18

18

17
17

17

16

16

16

16

15

14

14

14

14

14

14

14

13
13

13

13

13

13

13

12

12

12

11

11

11

11

10

10
10

10

10

10

10

10

10

8
7

5
5

4
4

4
4

3
3

3
2

2
2

1
1

1
1

1
1

1
1

1
1

1
1

1
Center Name Cite Id Ref No Short Desc

Human tissue for 12221 21 CFR 1271.47(a) Procedures for all steps
transplantation

12336 21 CFR 1271.180(a) Procedures to meet core CTGP

12311 21 CFR 1271.160(b)(1) Ensuring appropriate core

requirements followed

12277 21 CFR 1271.75(a)(1) Risk factors, clinical evidence

12326 21 CFR 1271.160(c) Quality audits performed periodically

12369 21 CFR 1271.200(b) Procedures inadequate

12411 21 CFR 1271.260(a) Contamination, mix ups, improper

release

12437 21 CFR 1271.270(a) Records incomplete

15020 21 CFR 1271.200(e) Documentation of maintenance and

cleaning

12283 21 CFR 1271.75(e) Abbreviated procedure

12287 21 CFR 1271.80(c) Kits not FDA approved, specifically

labeled

12310 21 CFR 1271.160(a) All core requirements covered in

program

12322 21 CFR 1271.160(b)(4) Training of personnel

12324 21 CFR 1271.160(b)(6) Deviations--Investigation, documenting,

trending
12334 21 CFR 1271.170(c) Trained or re-trained as necessary

12416 21 CFR 1271.260(e) Storage temperatures recorded,

maintained

12431 21 CFR 1271.265(e) Procedures and release criteria

12435 21 CFR 1271.270(a) Records maintained concurrently

12436 21 CFR 1271.270(a) Accurate, indelible, legible

12286 21 CFR 1271.80(b) Specimen collections not timely

12301 21 CFR 1271.150(c)(1) Ensurane of compliance

(iii)

12323 21 CFR 1271.160(b)(5) Monitoring systems

12363 21 CFR 1271.195(c) Monitoring--cross contamination,

exposure to CD

12381 21 CFR 1271.210(d)(2) Verification elements

3736 21 CFR 1270.31(b) Assessment of relevant medical

records

12213 21 CFR 1271.47(a) Donor eligibility procedures

12237 21 CFR 1271.55(a)(3) Summary--records used to make

determination

12238 21 CFR 1271.55(b)(1) Statement re: certified testing lab

12332 21 CFR 1271.170(b) Qualifications lacking

12365 21 CFR 1271.195(d) Documentation not maintained

12372 21 CFR 1271.200(c) Calibrated per established schedules

12375 21 CFR 1271.210(a) Use prior to verification

12417 21 CFR 1271.260(e) Periodic review of temperatures

12428 21 CFR 1271.265(c)(3) Departures: recorded and justified

12447 21 CFR 1271.290(b) Establishing a system

12453 21 CFR 1271.290(e) Documenting disposition of each

HCT/P

12223 21 CFR 1271.47(b) Review and approval of procedures

12224 21 CFR 1271.47(c) Availability of procedures

12229 21 CFR 1271.50(a) Determination based on screening and

testing

12230 21 CFR 1271.50(a) Responsible person to determine,

document

12288 21 CFR 1271.80(c) Manufacturer instructions not followed

12309 21 CFR 1271.160(a) Program is appropriate for the HCT/Ps

12319 21 CFR 1271.160(b)(3) Actions taken and documented

12320 21 CFR 1271.160(b)(3) Actions verified, short and long term

solutions
12325 21 CFR 1271.160(b)(6) Deviations--evaluation, cause,
corrective action

12343 21 CFR 1271.190(a) State of repair

12351 21 CFR 1271.190(d)(1) Procedures for cleaning, sanitation

12354 21 CFR 1271.190(d)(2) Documentation of activities

12371 21 CFR 1271.200(a) Cleaned, sanitized per established

schedules

12377 21 CFR 1271.210(c) In-house reagent production

12382 21 CFR 1271.210(d)(3) Lot documentation maintained

12389 21 CFR 1271.220(c) Specified requirements for in-process

controls

12408 21 CFR 1271.250(c) All labeling requirements met

12421 21 CFR 1271.265(a) Acceptance criteria designed to

prevent CD

12494 21 CFR 1271.85(c) Reproductive cells or tissues

3724 21 CFR 1270.21(f) Donor identity, relevant records

12222 21 CFR 1271.47(a) Design of procedures to ensure

compliance

12225 21 CFR 1271.47(d) Departures: recording and justifying

12240 21 CFR 1271.55(b)(3) Name and address on summary

12281 21 CFR 1271.75(c) Reproductive cells/tissues-Chlamydia,
Neisseria

12290 21 CFR 1271.80(d)(1) Reactive tests--not determined

ineligible

12314 21 CFR 1217.160(b)(2) Risk assessment, quarantine, recall,

(iii) FDA

12315 21 CFR 1271.160(b)(2) Sharing of information (general)

12316 21 CFR 1271.160(b)(2) Other establishments - same donor

(i) involved

12328 21 CFR 1271.160(d) Validation for intended use

12331 21 CFR 1271.170(a) Sufficient number

12337 21 CFR 1271.180(a) Design adequate to bar spread of CD's

12338 21 CFR 1271.180(b) Review and approval-responsible

person

12339 21 CFR 1271.180(c) Availability of procedures

12356 21 CFR 1271.195(a) Adequate control, proper conditions

12358 21 CFR 1271.195(a)(2) Ventilation and air filtration controls

12359 21 CFR 1271.195(a)(3) Aseptic processing---cleaning,

disinfecting

12398 21 CFR 1271.230(a) Validation & approval--established

procedures

12399 21 CFR 1271.230(a) Process validation procedures

12414 21 CFR 1271.260(d) Corrective actions

12415 21 CFR 1271.260(e) Temperature limits

12423 21 CFR 1271.265(b) Shipment in quarantine of HCT/Ps

12429 21 CFR 1271.265(d) Shipping conditions appropriate

12433 21 CFR 1271.265(f) Return to inventory--procedures

12438 21 CFR 1271.270(b) Management system re: core CGTPs

12479 21 CFR 1271.370(b)(4) Warnings on label

12492 21 CFR 1271.85(a) Infection with communicable disease

agents

12493 21 CFR 1271.90(b) Eligibility not required--warning labels

3722 21 CFR 1270.21(e) Accompanying donor records

3723 21 CFR 1270.21(e) Person responsible

3740 21 CFR 1270.31(d) Prevention of cross-contamination

3744 21 CFR 1270.33(a) Accurate, indelible, legible

3745 21 CFR 1270.33(a) Person involved, dates, details

3749 21 CFR 1270.33(d) Determination of suitability

 3750 21 CFR 1270.33(d) Completion and review of testing &
screening

3751 21 CFR 1270.33(e) Quarantine until release or disposition

3752 21 CFR 1270.33(f) Make available to FDA

3754 21 CFR 1270.33(h) Retention for 10 years

3758 21 CFR 1270.35(c) Receipt and/or distribution

12226 21 CFR 1271.47(d) Determining risks when departures

involved

12227 21 CFR 1271.47(e) Adopting procedures from another

organization

12236 21 CFR 1271.55(a)(2) Eligibility statement--basis of

determination

12239 21 CFR 1271.55(b)(2) Listing and interpretation of CD tests

performed

12242 21 CFR 1271.55(c) Name and personal info on

accompanying records

12245 21 CFR 1271.55(d)(1) Results, interpretation of CD screening

(ii)

12246 21 CFR 1271.55(d)(1) Documentation--determination, by

(iii) whom, date

12249 21 CFR 1271.55(d)(3) Records not made available to FDA

12254 21 CFR 1271.60(b) Identified as quarantined,

distinguishable

12258 21 CFR 1271.60(c)(3) Statement of restrictions

12264 21 CFR 1271.60(d)(2) Results of completed donor testing
(ii)

12267 21 CFR 1271.60(d)(4) Eligibility determination not completed

12275 21 CFR 1271.65(c) Nonclinical use--label requirements

12278 21 CFR 1271.75(a)(2) Risks associated with

xenotransplantation

12312 21 CFR 1271.160(b)(2) Procedures for complaints and other

information

12321 21 CFR 1271.160(b)(3) Problem description, disposition, date

et. al.

12329 21 CFR 1271.160(d) Documentation/approval prior to

implementation

12333 21 CFR 1271.170(b) Not qualified, authorized for functions

12340 21 CFR 1271.180(d) Adopted from another organization

12342 21 CFR 1271.190(a) Size, construction, location--prevent

mix-ups etc.

12345 21 CFR 1271.190(b)(1) Clean, sanitary, orderly manner

12349 21 CFR 1271.190(c) Control system

12362 21 CFR 1271.195(b) Corrective actions

12367 21 CFR 1271.200(a) Design appropriate, suitably located

12370 21 CFR 1271.200(c) Calibration procedures and schedules

(general)
12373 21 CFR 1271.200(d) Inspected routinely

12378 21 CFR 1271.210(d)(1) Receipt documentation maintained

12379 21 CFR 1271.210(d)(1) Receipt documentation elements

12380 21 CFR 1271.210(d)(2) Verification documentation maintained

12384 21 CFR 1271.215 Potential problems with recovery

12396 21 CFR 1271.225 Approval and timely communication

12400 21 CFR 1271.230(a) Documented, dated, signed

12401 21 CFR 1271.230(b) Reduced risk representation

12407 21 CFR 1271.250(b) Verification of label accuracy, legibility,

integrity

12409 21 CFR 1271.250(c) Documentation of donor eligibility

12412 21 CFR 1271.260(b) Storage temperatures appropriate

12413 21 CFR 1271.260(c) Expiration date factors

12419 21 CFR 1271.265(a) Evaluation--microorganisms, damage

12425 21 CFR 1271.265(c)(1) Release of HCT/Ps by responsible

person

12427 21 CFR 1271.265(c)(3) HCT/Ps made under departure from

process
12432 21 CFR 1271.265(e) Documentation elements for activities

12443 21 CFR 1271.270(d) Retention time (10 year rules)

12457 21 CFR 1271.320(a) Procedures re complaints

12463 21 CFR 1271.320(c) Documentation of decision not to

investigate

12470 21 CFR 1271.350(a)(2) 15 day reporting timeframe

12472 21 CFR 1271.350(b)(1) Deviations not investigated

12473 21 CFR 1271.350(b)(2) Deviations not reported to FDA

12489 21 CFR 1271.90(b)(1) Autologous use only--labeling

12496 21 CFR 1271.85(b)(2) SOP for release; reactive for CMV

15023 21 CFR 1271.270(b) Management system, other records

15025 21 CFR 1271.85(b)(2) Cytomegalovirus (CMV)

Long Desc

Procedures for all steps performed in the [testing] [screening] [determining] of donor eligibility of HCT/Ps were not [established] [maintained]
[defined] [documented] [implemented] [followed] [reviewed] [revised]. Specifically, ***

Procedures appropriate to meet core CGTP requirements for all steps that you perform in the manufacture of HCT/Ps were not [established]
[maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised]. Specifically, ***

The quality program has not ensured that appropriate procedures related to core CGTP requirements were [established] [maintained]
[defined] [documented] [implemented] [followed] [reviewed] [approved] [revised]. Specifically, ***

Donors were not screened by a review of relevant medical records for [risk factors] [clinical evidence] of communicable disease agents and
diseases. Specifically, ***

Periodic quality audits of activities related to core CGTP requirements have not been performed. Specifically, ***

Procedures for the [cleaning] [sanitizing] [maintenance] of equipment were not [established] [maintained] [defined] [documented]
[implemented] [followed] [revised]. Specifically, ***

Storage areas and stock rooms were not controlled [to prevent mix-ups, contamination and cross contamination of HCT/Ps, supplies and
reagents] [to prevent HCT/Ps from improperly being made available for distribution]. Specifically, ***

Records [did not identify the person performing the work] [did not show the dates of entries] [were not detailed as necessary to provide a
complete history of work performed] [did not relate to the HCT/P involved]. Specifically, ***

Documentation of equipment maintenance, cleaning, sanitization, and calibration was not maintained. Specifically, ***

The abbreviated donor screening procedure [was used for donors who had no complete donor screening procedure in the previous six
months] [did not determine and document changes in the donor's medical history that would make the donor ineligible]. Specifically, ***

Communicable disease agent tests [were not FDA-licensed, approved or cleared donor screening tests] [were not specifically labeled for
cadaveric specimens when such a test was available and cadaveric specimens were used]. Specifically, ***

A quality program which addresses all of the core CGTP requirements, appropriate for the HCT/Ps manufactured and the manufacturing
steps performed, has not been [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised]. Specifically,
***

The quality program has not ensured the proper training and education of personnel involved in core GTP activities. Specifically, ***

The quality program does not include [the investigation] [the documentation] [the trending] [the reporting] of HCT/P deviations relating to
core CTGP requirements. Specifically, ***
Personnel have not been [trained] [re-trained as necessary] to adequately perform their assigned responsibilities. Specifically, ***

Storage temperatures of HCT/Ps were not [recorded] [maintained]. Specifically, ***

Procedures including release criteria for activities relating to the [receipt] [shipment] [distribution] of HCT/Ps were not [established]
[maintained] [documented] [implemented] [followed] [reviewed] [revised]. Specifically, ***

Records were not maintained concurrently with the performance of each step. Specifically, ***

Records were not [accurate] [indelible] [legible]. Specifically, ***

Donor specimens used for testing of communicable disease agents were not collected at the appropriate time. Specifically, ***

You did not ensure that establishment(s) that by contract, agreement or arrangement, perform manufacturing steps for you were in
compliance with [applicable CGTP requirements prior to the initiation of the contract, agreement of arrangement] [applicable CGTP
requirements after information became available that suggested the establishment was no longer in compliance]. Specifically, ***

The quality program has not established and maintained appropriate monitoring systems. Specifically, ***

Environmental conditions are not monitored when such conditions could cause [contamination or cross contamination of HCT/Ps or
equipment] [the accidental exposure of HCT/Ps to communicable disease agents]. Specifically, ***

Documentation of the verification of [supplies] [reagents] did not include [test results] [a certificate of analysis from the vendor]. Specifically,
***

Failure to [prepare] [follow] written procedures for all significant steps for [obtaining] [reviewing] [assessing] the relevant medical records of a
donor. Specifically, ***

Procedures for all steps performed in the [testing] [screening] [determining] of donor eligibility of HCT/Ps were not [established] [maintained]
[defined] [documented] [implemented] [followed] [reviewed] [revised]. Specifically, ***

After completion of the donor-eligibility determination, HCT/Ps were not accompanied with the summary of the records used to make the
donor-eligibility determination. Specifically, ***

The summary of records for HCT/Ps did not contain a statement that the communicable disease testing was performed by a laboratory
certified to perform such testing on human specimens under the Clinical Laboratory Improvement Act of 1988 or has met equivalent
requirements determined by the Centers for Medicare and Medicaid Services. Specifically, ***

Personnel do not have the necessary [education] [experience] [training] to ensure competent performance of their assigned functions.
Specifically, ***
Documentation of environmental control and monitoring activities was not maintained. Specifically, ***

Equipment used for [inspection] [measuring] [testing] was not calibrated according to established schedules. Specifically, ***

Supplies and reagents were used before they were verified to meet specifications designed to prevent the introduction, transmission, or
spread of communicable disease. Specifically, ***

Recorded storage temperatures were not periodically reviewed to ensure that temperatures have been within acceptable limits. Specifically,
***

Departures from procedures were not [recorded] [justified] at the time of occurrence. Specifically, ***

A tracking system that enables the tracking of HCT/Ps back and forth from the donor to the consignee or final disposition was not
[established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised]. Specifically, ****

A method has not been [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised] in the tracking
system [to document the disposition of each HCT/P] [to permit the prompt identification of the consignee of the HCT/P, if any]. Specifically,
***

Donor eligibility procedures were not [reviewed] [approved] by a responsible person before implementation. Specifically, ***

Donor eligibility procedures were not available to personnel in the area where operations are performed, or in a nearby area when such
availability is impractical. Specifically, ***

HCT/P donors were not determined to be eligible based on the results of donor screening and testing. Specifically, ***

The eligibility of an HCT/P donor was not [determined] [documented] by a responsible person, based on results of donor screening and
donor testing. Specifically, ***

Testing for communicable disease agents was not performed in accordance with the manufacturer's instructions. Specifically, ***

A quality program appropriate for the HCT/Ps manufactured and manufacturing steps performed has not been [established] [maintained]
[defined] [documented] [implemented] [followed] [reviewed] [revised]. Specifically, ***

The quality program has not ensured that appropriate corrective actions relating to core CGTP requirements are [taken] [documented].
Specifically, ***

Corrective actions relating to core CGTP requirements [have not been verified to ensure effectiveness and compliance with CGTP] [did not
include both short term corrective actions to address the immediate deficiency and long term corrective actions to prevent recurrence].
Specifically, ***
Investigation of deviations related to core CGTP requirements did not include [a review and evaluation of the deviation] [efforts to determine
the cause of the deviation] [corrective action(s) to address the deviation and prevent recurrence]. Specifically, ***

Facilities were not maintained in a good state of repair. Specifically, ***

Procedures for facility cleaning and sanitation were not [established] [maintained] [defined] [documented] [implemented] [followed] [revised].
Specifically, ***

Documentation of facility cleaning and sanitation activities was not maintained. Specifically, ***

Equipment used for manufacturing HCT/Ps was not [cleaned] [sanitized] [maintained] according to established schedules. Specifically, ***

The processes used for the production of in-house reagents were not [validated] [verified]. Specifically, ***

Documentation of the lot of [supplies] [reagents] used in the manufacture of each HCT/P was not maintained. Specifically, ***

Specified requirements for in-process controls were not met. Specifically, ***

Labeling procedures did not ensure that HCT/Ps are labeled in accordance with all labeling requirements. Specifically, ***

Incoming HCT/Ps were not [accepted] [rejected] [placed in quarantine] based on pre-established criteria designed to prevent communicable
disease transmission. Specifically, ***

Donors of reproductive cells or tissues not recovered by a method that ensures freedom from contamination were not tested for
communicable diseases of the genitourinary tract. Specifically, ***

The determination by a responsible person that the human tissue was suitable for transplantation did not include [donor identity] [relevant
medical records as defined in 21 CFR 1270.3(t)]. Specifically, ***

Procedures were not designed to ensure compliance with the donor eligibility requirements. Specifically, ***

Departures from donor eligibility procedures relevant to preventing risks of communicable disease transmission were not [recorded]
[justified]. Specifically, ***

The summary of records for HCT/Ps did not contain the [name] [address] of the establishment that made the donor-eligibility determination.
Specifically, ***
Donors of reproductive cells or tissues not recovered by a method that ensures freedom from contamination were not screened by a review
of relevant medical records for [risk factors] [clinical evidence] of [Chlamydia trachomatis] [Neisseria gonorrhea]. Specifically, ***

Donors whose specimens test reactive on screening tests for communicable disease agents were not determined to be ineligible.
Specifically, ***

The quality program has not ensured that procedures include provisions for [assessing the risk of] [quarantine of] [recall of] [reporting to FDA
on] HCT/Ps that have been made available for distribution and for which there is information related to the possible contamination or
communicable disease transmission. Specifically, ***

The quality program has not ensured that procedures exist for sharing of information pertaining to the possible contamination or
communicable disease transmission of HCT/Ps. Specifically, ***

The quality program has not ensured that procedures exist for sharing information pertaining to the possible contamination of the HCT/P, or
the potential for transmission of a communicable disease by the HCT/P, with other establishments that are known to have recovered HCT/Ps
from the same donor. Specifically, ***

The performance of [custom computer software] [commercial computer software that has been customized or programmed], including
changes to computer software, has not been validated for the intended use, when such software is relied upon to comply with core GTP
requirements. Specifically, ***

Personnel are not sufficient to ensure compliance with the requirements. Specifically, ***

Procedures were not designed to prevent circumstances that increase the risk of communicable disease introduction, transmission and
spread through the use of HCT/Ps. Specifically, ***

Procedures for core CGTP requirements were not [reviewed] [approved] by a responsible person before implementation. Specifically, ***

Procedures for core CTGP requirements were not available to personnel in the area where operations are performed, or in a nearby area
when such availability is impractical. Specifically, ***

Environmental conditions existed in which [contamination or cross contamination of HCT/Ps or equipment] [the accidental exposure of
HCT/Ps to communicable disease agents] could occur, and [environmental conditions were not adequately controlled] [proper conditions for
operations were not provided]. Specifically, ***

Environmental controls do not provide for adequate [ventilation] [air filtration]. Specifically, ***

Environmental controls do not provide for adequate [cleaning] [disinfecting] of [rooms] [equipment] to ensure aseptic processing.
Specifically, ***

Processes with results which could not be fully verified by inspection and tests, were not validated and approved according to established
procedures. Specifically, ***

Procedures to validate and approve processes that cannot be fully verified by inspection and tests were not [established] [maintained]
[defined] [documented] [implemented] [followed] [reviewed] [revised]. Specifically, ***
Corrective actions were not [performed] [documented] when proper storage conditions were not met. Specifically, ***

Acceptable temperature limits were not established for the storage of HCT/Ps at each step of the manufacturing process to inhibit the growth
of infectious agents. Specifically, ***

HCT/Ps shipped as pre-distribution shipments [within your establishment] [between establishments] which do not meet the criteria for being
available for distribution were not shipped in quarantine. Specifically, ***

Appropriate shipping conditions were not [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised] for
each type of HCT/P. Specifically, ***

Procedures for determining if HCT/Ps that were returned to the establishment are suitable to be returned to inventory were not [established]
[maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised]. Specifically, ***

A records management system relating to core CGTP requirements was not [established] [maintained] [defined] [documented]
[implemented] [followed] [reviewed] [revised]. Specifically, ***

HCT/Ps made available for distribution were not labeled with or accompanied by applicable warnings. Specifically, ***

Donors were not tested for evidence of infection with communicable disease agents. Specifically, ***

HCT/Ps for which the donor eligibility determination was not performed were not prominently labeled with the appropriate warning
statements. Specifically, ***

Human tissue intended for transplantation was not accompanied by a summary or copies of the donor's relevant medical records as defined
in 21 CFR 1270.3(t). Specifically, ***

The summary or copies of the donor's relevant medical records as defined in 21 CFR 1270.3(t) failed to designate and identify the person
responsible for making the determination that the human tissue was suitable for transplantation. Specifically, ***

Failure to [prepare] [validate] [follow] written procedures for prevention of [infectious disease contamination] [cross-contamination] during
processing. Specifically, ***

Failure to maintain records which are [accurate] [indelible] [legible]. Specifically, ***

Records fail to [identify the person performing the work] [include the dates of the various entries] [be as detailed as necessary to provide a
complete history of the work performed and to relate the records to the particular tissue involved]. Specifically, ***

Failure to accompany tissue which has been determined to be suitable for transplantation with a summary or copy of original records
documenting that the tissue has been so determined. Specifically, ***
Failure to accompany tissue which has been determined to be suitable for transplantation with a summary or copy of original records
documenting that all infectious testing and screening have been [completed] [reviewed] [found to be negative]. Specifically, ***

Failure to quarantine tissue until [it has been determined to be suitable for transplantation] [appropriate disposition has been accomplished].
Specifically, ***

Failure to make available for inspection or upon request by FDA, records regarding donor suitability, including all testing and screening
records. Specifically, ***

Failure to retain records regarding donor suitability for at least 10 years beyond the date of transplantation if known, distribution, disposition,
or expiration of the tissue, whichever is latest. Specifically, ***

Records fail to include documentation of receipt and/or distribution of human tissue. Specifically, ***

A determination that departures from donor eligibility procedures did not increase the risk of communicable disease transmission was not
made by a responsible person prior to making an HCT/P available for distribution. Specifically, ***

Current donor eligibility procedures adopted from another organization were not verified to be [consistent with the donor eligibility
requirements specified in the regulations] [appropriate for your operations]. Specifically, ***

After the completion of the donor-eligibility determination, HCT/Ps were not accompanied with a statement whether the donor has been
determined to be eligible or ineligible, based on the results of screening and testing. Specifically, ***

The summary of records for HCT/Ps did not contain [a listing] [an interpretation of results] of all communicable disease tests performed.
Specifically, ***

The accompanying records for HCT/Ps included [the donor's name] [personal information that might identify the donor]. Specifically, ***

Documentation of [the results] [the interpretation] of all donor screening for communicable diseases was not maintained. Specifically, *

Documentation of [the donor-eligibility determination] [the responsible person who made the donor-eligibility determination] [the date of the
donor-eligibility determination] was not maintained. Specifically, ***

Required donor eligibility records were not made available for authorized inspection or upon request by FDA. Specifically, ***

HCT/Ps in quarantine pending completion of the donor eligibility determination were [not clearly identified as quarantined] [not easily
distinguishable from HCT/Ps available for release and distribution]. Specifically, ***

HCT/Ps shipped in quarantine prior to the completion of the donor-eligibility determination were not accompanied by records that stated the
product must not be implanted, transplanted, infused or transferred until completion of the donor-eligibility determination. Specifically, ***
HCT/Ps made available for use in cases of urgent medical need were not accompanied by the results of any donor testing that has been
completed. Specifically, ***

The donor-eligibility determination was not completed for HCT/Ps used in cases of urgent medical need. Specifically, ***

HCT/Ps from ineligible donors which were made available for nonclinical use were not labeled ["For Nonclinical Use Only"] [with the
Biohazard legend]. Specifically, ***

Donors were not screened by a review of relevant medical records for disease risks associated with xenotransplantation. Specifically, ***

The quality program has not ensured that procedures exist for [receiving] [investigating] [evaluating] [documenting] information relating to
core CGTP requirements, including complaints.

Documentation of corrective actions did not include [a description of the HCT/Ps] [the disposition] [the nature of the problem] [the description
of the corrective action] [the date of the corrective action]. Specifically, ***

Computer software [validation] [verification] activities and results have not been [documented] [approved] prior to implementation.
Specifically, ***

Personnel perform functions for which they are not [qualified] [authorized]. Specifically, ***

Current standard procedures adopted from another organization were [not verified to be consistent with the requirements of the CGTP
regulations] [not appropriate for your operations]. Specifically, ***

Facilities were not of suitable [size] [construction] [location] to [prevent contamination of HCT/Ps with communicable disease agents] [ensure
the orderly handling of HCT/Ps without mix-ups]. Specifically, ***

Facilities were not maintained in a [clean] [sanitary] [orderly] manner to prevent the introduction, transmission, or spread of communicable
disease. Specifically, ***

Operations were not controlled with a system [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised]
to prevent [improper labeling] [mix-ups] [contamination] [cross contamination] [accidental exposure of HCT/Ps to communicable disease
agents]. Specifically, ***

Appropriate corrective actions were not taken related to the inspections of environmental control systems. Specifically, ***

Equipment used in the manufacture of HCT/Ps was [not of appropriate design for its use] [not suitably located to facilitate operations,
cleaning and maintenance]. Specifically, ***

The [procedures] [schedules] for the calibration of equipment used for [inspection] [measuring] [testing] were not [established] [maintained]
[defined] [documented] [implemented] [followed] [reviewed] [revised]. Specifically, ***
Equipment was not routinely inspected for [cleanliness] [sanitation] [calibration] [adherence to maintenance schedules]. Specifically, ***

Documentation of the receipt of [supplies] [reagents] was not maintained. Specifically, ***

The documentation for the receipt of [supplies] [reagents] did not include [the type] [the quantity] [the manufacturer] [the lot number] [the
date of receipt] [the expiration date]. Specifically, ***

Documentation of the verification of [supplies] [reagents] was not maintained. Specifically, ***

HCT/Ps were not recovered in a way [that does not cause contamination or cross contamination during recovery] [that does not increase the
risk of introduction, transmission or spread of communicable disease]. Specifically, ***

Process changes were [not approved by a responsible person with appropriate knowledge and background prior to implementation] [not
communicated to personnel in a timely manner]. Specifically, ***

The validation [activities] [results] were not [documented] [dated and signed by the individual(s) approving the validation]. Specifically, ***

Written representation that processing methods reduce the risk of transmission of communicable disease by HCT/Ps was not based on a
fully validated or verified process. Specifically, ***

Labeling procedures did not include verification of label [accuracy] [legibility] [integrity]. Specifically, ***

Labeling procedures did not ensure that HCT/Ps made available for distribution are accompanied by documentation of the donor eligibility
determination. Specifically, ***

HCT/Ps were not stored at appropriate temperatures. Specifically, ***

HCT/Ps were not assigned an expiration date based on [type of HCT/P] [processing, including method of preservation] [storage conditions]
[packaging]. Specifically, ***

Incoming HCT/Ps were [not evaluated for the presence and significance of microorganisms] [not inspected for damage and contamination].
Specifically, ***

A responsible person did not [document] [date] the determination that an HCT/P is available for distribution. Specifically, ***

A responsible person did not determine that HCT/Ps manufactured under a departure from procedures do not increase the risk of
communicable disease prior to making the HCT/Ps available for distribution. Specifically, ***
Documentation for activities related to the [receipt] [shipment] [distribution] of HCT/Ps did not include [identification of the HCT/P and the
establishment that supplied the HCT/P] [activities performed and the results of each activity] [date(s) of activity] [quantity of HCT/P subject to
the activity] [disposition of the HCT/P (identity of consignee)]. Specifically, ***

Records were not retained for the appropriate length of time, [10 years after their creation] [at least 10 years after the date of administration
of a particular HCT/P] [at least 10 years after the date of a particular HCT/Ps distribution, disposition, or expiration, whichever is latest, when
the date of administration is not known] [10 years after the appropriate disposition of archived specimens of dura mater]. Specifically, ***

Procedures for the [review] [evaluation] [documentation] [investigation] of complaints relating to core CGTP requirements were not
[established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised]. Specifically, ***

When no investigation of a complaint was made for an event that is not required to be reported to FDA, a record of [the reason no
investigation was made] [the individual responsible for making that decision] was not maintained. Specifically, ***

Adverse reactions were not reported to FDA using form FDA 3500A within 15 calendar days of initial receipt of information. Specifically, ***

HCT/P deviations related to distributed HCT/Ps for which the establishment performed a manufacturing step were not investigated.
Specifically, ***

HCT/P deviations relating to core CGTP requirements that occurred [in your establishment] [at an establishment under contract, agreement,
or arrangement with your establishment] were not reported to FDA. Specifically, ***

HCT/Ps for autologous use and for which the donor eligibility determination was not performed were not labeled for autologous use only.
Specifically, ***

A standard operating procedure for the release of HCT/Ps from donors that test reactive for cytomegalovirus (CMV) was not [established]
[maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised]. Specifically. ***

Records pertinent to the manufacture of HCT/Ps were not maintained and organized under the records management system. Specifically,
***

Donors of viable, leukocyte-rich cells or tissue were not tested for evidence of infection due to cytomegalovirus (CMV). Specifically, ***
Frqncy

18

16

10

6
6

4
4

3
3

2
2

2
2

1
1

1
1

1
1

1
1

1
Center Name Cite Id Ref No Short Desc

Parts 1240 and 7036 21 CFR 1250.67 Prevention of contamination

1250

7032 21 CFR 1250.63 Prevention of the spread of

communicable diseases

6569 21 CFR 1250.33(b) Equipment kept clean

6560 21 CFR 1250.32(a) Contamination

6552 21 CFR 1250.28 Handling to avoid contamination

6570 21 CFR 1250.33(c) Storage and handling after

bactericidal treatment

6558 21 CFR 1250.30(d) Plumbing design, installation,

maintenance

6564 21 CFR 1250.33(a) Maintained in good repair

6581 21 CFR 1250.38(b) Soap, sanitary towels, water

6580 21 CFR 1250.38(b) Signs

6591 21 CFR 1250.42(a) Backflow protection

6572 21 CFR 1250.34 Thermometers

6579 21 CFR 1250.38(a) Suitable design and construction

6555 21 CFR 1250.30(a) Clean and free from flies,

rodents, and other vermin
7055 21 CFR 1250.75(b) Equipment for cleaning and
flushing

6565 21 CFR 1250.33(a) Adequate facilities for cleaning,

bactericidal treatment

6567 21 CFR 1250.33(b) Cleaning of multiuse eating and

drinking utensils

7051 21 CFR 1250.75(a) Contamination of passenger

stations

6525 21 CFR 1240.86 Lack of backflow prevention

6554 21 CFR 1250.30(a) Ventilation and lighting

6593 21 CFR 1250.42(b) Connections easily cleanable,

located and protected

7053 21 CFR 1250.75(b) Sanitary sewers or alternative

methods

7090 21 CFR 1250.82(e) Backflow prevention - general

6549 21 CFR 1250.27 Storage of perishables

6609 21 CFR 1250.49 Clean and free of flies and

mosquitoes

7039 21 CFR 1250.67 Bulk ice

6561 21 CFR 1250.32(b) Clean hands

6563 21 CFR 1250.33(a) Easily cleaned, self-draining

6582 21 CFR 1250.38(b) Maintained in clean condition

6586 21 CFR 1250.39 Frequency of disposition

7041 21 CFR 1250.70(a) Adequate and readily accessible

7056 21 CFR 1250.75(c) Persons handling soil cans and

other containers

7089 21 CFR 1250.82(d) Identification marks on tanks and

piping

6585 21 CFR 1250.39 Containers - close-fitting covers

7118 21 CFR 1250.90 Clean condition

6503 21 CFR 1240.60(a) Handled or stored in an

insanitary manner

6505 21 CFR 1240.60(b) Lack of tag on shellstock

6509 21 CFR 1240.61(b) Inadequate pasteurization

6531 21 CFR 1250.22 Clean, wholesome, free from

spoilage

6557 21 CFR 1250.30(c) Water supply

6568 21 CFR 1250.33(b) Cleaning of all other utensils

6573 21 CFR 1250.34 Backflow protection for waste

water drains

6584 21 CFR 1250.39 Containers - watertight, readily

cleanable, non-absorbent

6588 21 CFR 1250.41 Submittal of construction plans

6590 21 CFR 1250.42(a) Complete and closed

6596 21 CFR 1250.42(d) Water filters

6612 21 CFR 1250.50 Designed to permit ready

cleaning

7038 21 CFR 1250.67 Signs for non-potable water

7054 21 CFR 1250.75(b) Soil cans and removable

containers

7058 21 CFR 1250.79(a) Container construction

7121 21 CFR 1250.96 Rodent infestation

Long Desc

Failure to [design] [construct] [maintain] [operate] servicing area [piping systems] [hydrants] [taps] [faucets] [hoses] [buckets] [equipment] in
such a manner as to prevent contamination of [drinking] [culinary] water. Specifically, ***

Servicing area are not [provided with all necessary sanitary facilities] [operated] [maintained] as to prevent the spread of communicable
diseases. Specifically, ***

Failure to keep all equipment clean. Specifically, ***

Not all food-handling operations are accomplished so as to minimize the possibility of contaminating [food] [drink] [utensils]. Specifically, ***

Ice coming into contact with [food] [drink] is not [handled] [stored] in such a manner as to avoid contamination. Specifically, ***

Failure to [store] [handle] utensils, after bactericidal treatment, in such a manner as to prevent contamination before reuse. Specifically, ***

Plumbing is not [designed] [installed] [maintained] so as to prevent contamination of [the water supply] [food] [food utensils]. Specifically, ***

Not all [utensils] [working surfaces] used in connection with [preparation] [storage] [serving] of [food] [beverages] are maintained in good
repair. Specifically, ***

Hand washing facilities for use by food-handling employees lack [soap] [sanitary towels] [hot and cold running water]. Specifically, ***

Signs directing food-handling employees to wash their hands after each use of toilet facilities are not [posted] [readily observable by such
employees]. Specifically, ***

A water system not protected against backflow. Specifically, ***

Failure to equip each refrigerator with a thermometer located in the warmest region thereof. Specifically, ***

Failure to provide [toilet] [lavatory] facilities of suitable design and construction for use by food-handling employees. Specifically, ***

Not all [kitchens] [galleys] [pantries] [places] where food is prepared, served, or stored are [clean] [free from flies, rodents, and other vermin].
Specifically, ***
Equipment for [cleaning soil cans and removable containers] [flushing nonremovable containers and waste carts] is [not designed so as to
prevent backflow into the water line] [used for a purpose connected with the handling of food, water, or ice]. Specifically, ***

Adequate facilities are not provided for the [cleaning] [bactericidal treatment] of [multiuse eating and drinking utensils] [equipment used in
the preparation of food and beverages]. Specifically, ***

Failure to [thoroughly clean in warm water] [subject to an effective bactericidal treatment] multiuse eating and drinking utensils after each
use. Specifically, ***

Failure to dispose of human wastes in such a manner as to avoid contamination of passenger [areas] [stations]. Specifically, ***

A connection exists between a nonpotable water system on [a vessel] [your vessel] and a potable water system on [a] [your] pier; there are
no provisions to prevent backflow from the vessel to the pier.

Not all [kitchens] [galleys] [pantries] [places] where food is prepared, served, or stored are adequately [lighted] [ventilated]. Specifically, ***

Filling connections not [easily cleanable] [located and protected] so as to minimize the hazard of contamination of the water supply.
Specifically, ***

Failure to dispose of toilet wastes through [sanitary sewers] [methods assuring sanitary disposal]. Specifically, ***

Lack of backflow prevention in the installation of [pipes] [fittings] conveying potable water to [fixtures] [apparatus] [equipment]. Specifically,
***

Failure to keep perishable [food] [drink] at or below 50 degrees Fahrenheit except when being prepared or kept hot for serving. Specifically,
***

Not all conveyances were kept [clean] [free of flies and mosquitoes] while in transit. Specifically, ***

Equipment used to [store] [wash] [handle] [deliver] bulk ice intended for [the cooling of drinking water or other beverages] [food preservation
purposes] is not [constructed so as not to become a factor in the transmission of communicable diseases] [used for no other purposes].
Specifically, ***

Persons with unclean hands were engaged in handling [food] [drink] [utensils] [equipment]. Specifically, ***

Not all [utensils] [working surfaces] used in connection with [preparation] [storage] [serving] of [food] [beverages] are constructed so as to be
[easily cleaned] [self-draining]. Specifically, ***

Failure to maintain toilet rooms in a clean condition. Specifically, ***

Failure to dispose of [garbage] [refuse] as frequently as necessary and practicable. Specifically, ***

Adequate [toilet] [washroom] [locker] [essential sanitary] facilities for use of employees are not readily accessible adjacent to [places] [areas]
where [land] [air] conveyances are [serviced] [maintained] [cleaned]. Specifically, ***

Persons who have handled [soil cans] [containers which have come in contact with human wastes] do not [wash their hands thoroughly with
soap and warm water] [remove any garments which have become soiled with human wastes] before engaging in work connected with the
[loading] [unloading] [transporting] [handling] of [food] [water] [ice]. Specifically, ***

Not all [tanks] [piping] bear clear marks of identification. Specifically, ***

Garbage containers lack close-fitting covers. Specifically, ***

Toilet and lavatory [equipment] [spaces] not maintained in a clean condition. Specifically, ***

Molluscan shellfish have been [handled] [stored] in such an insanitary manner that [they are likely to become agents in] [their transportation
is likely to contribute to] the spread of communicable disease. Specifically, ***

Shellstock fails to bear a tag that discloses [the date and place they were harvested (by State and site)] [type and quantity of shellfish] [by
whom they were harvested]. Specifically, ***

Pasteurization of [milk] [milk products] does not meet minimum time-temperature requirements. Specifically, ***

Not all [food] [drink] served onboard is [clean] [wholesome] [free from spoilage]. Specifically, ***

Water [of satisfactory sanitary quality] [under head of pressure] [adequate in amount and temperature] is not easily accessible to all rooms in
which [food is prepared] [utensils are cleaned]. Specifically, ***

Failure to [thoroughly clean in warm water] [subject to an effective bactericidal treatment] utensils (other than multiuse utensils) following the
day's operation. Specifically, ***

Waste water drains from [ice boxes] [refrigerating equipment] [refrigerated spaces] are not so installed as to prevent backflow of
contaminating liquids. Specifically, ***

Garbage containers are not [watertight] [readily cleanable] [non-absorbent]. Specifically, ***

Failure to submit plans for the [construction] [major reconstruction] of [sanitary equipment] [facilities] to FDA for review. Specifically, ***
A water system which is not [complete] [closed] from the filling ends to the discharge taps (except for protected vent openings). Specifically,
***

Failure to [operate] [maintain] water filters so as to prevent contamination of the water. Specifically, ***

Lack of design of [toilet] [lavatory] facilities so as to permit ready cleaning. Specifically, ***

Outlets for non-potable water are not posted with [permanent] signs warning that the water is unfit for drinking. Specifically, ***

Failure to [thoroughly] clean [soil cans] [removable containers] prior to return to use. Specifically, ***

Containers used to [receive] [store] garbage are not [water-tight] [readily cleanable] [nonabsorbent] [equipped with close-fitting covers].
Specifically, ***

Failure to prevent, through generally accepted methods of control, an infestation by rodents. Specifically, ***
Frqncy

64

45

37

36

28

27

25

23

21

19

19

16

16

9
8

3
3

1
1

1
Center Name Cite Id Ref No Short Desc

Radiological 5007 21 CFR 1002.13 Failure to submit

health

5032 21 CFR 1010.2(b) Certification label or tag

5700 21 CFR 1002.10 Failure to submit, distinct marking

Long Desc

You did not submit an annual report [by the September 1 deadline] for products requiring one. Specifically, ***

A certification label or tag is not [in the English language] [permanently affixed or inscribed] [legible] [readily accessible to view when the
product is fully assembled for use]. Specifically, ***

You did not submit a required product report [distinctly marked "Radiation Safety Product Report of (your name)"] prior to the introduction of
the product into commerce. Specifically, ***
Frqncy

1
Center Name Cite Id Ref No Short Desc

Veterinary 4185 FDCA 402(a)(4) Record keeping

medicine

4093 21 CFR 530.11(d) Tissue residue

7001 FDCA 402(a)(4) Drug inventory

4182 FDCA 501(a)(5) Extra label use w/o veterinary client-patient

relationship

1442 FDCA 402(a)(4) Records review prior to slaughter

4298 21 CFR 530.11(a) Rx not followed

4097 21 CFR 530.20(a)(2)(iv) Tissue residue

1360 FDCA 501(a)(5) Expired drugs

1366 21 CFR 530.11(a) Dosage level

1850 21 CFR 225.58(d) Assay results out of specification

4186 FDCA 402(a)(4) System for administration of drugs

1811 21 CFR 225.58(b)(1) Three assays per year

2076 21 CFR 225.102(b)(1) Elements of the MRF

2097 21 CFR 225.102(b)(4) Daily review of production records

 1373 21 CFR 530.11(a) Route of administration

1575 21 CFR 225.42(b)(4) Integrity and identity

1469 21 CFR 225.20(b)(3) Pest access minimized

13508 FDCA 402(a)(4) Medication status of animals

1466 21 CFR 225.20(b)(2) Maintained in clean and orderly condition

1923 21 CFR 225.65(b) Reasonable and effective procedures followed

1955 21 CFR 225.80(a) Appropriate labeling for medicated feed

2075 21 CFR 225.102(b)(1) Preparation of MRF

4100 21 CFR 530.20(a)(2)(iii) Identity of treated animals

4184 FDCA 501(a)(5) Conditions of use

4541 21 CFR 225.42(b) Adequate procedures established

13509 FDCA 402(a)(4) Identity of animals

1362 21 CFR 530.11(a) Species or class

1493 21 CFR 225.30(b)(4) Calibration of scales and metering devices

1782 21 CFR 225.42(b)(7) Daily comparison, actual vs theoretical

4132 21 CFR 589.2000(d)(1) Protein blenders, feed manufacturers, distributors

1821 21 CFR 225.58(b)(1) First batch assay

4137 21 CFR 589.2000(d)(1) Maintaining records

4146 21 CFR 589.2000(e)(1) Written clean-out procedures

4545 21 CFR 225.120 Vermin and pest infestation

1376 21 CFR 530.11(a) Frequency and duration

1744 21 CFR 225.42(b)(6) Daily inventory record kept

2093 21 CFR 225.102(b)(2)(i)-(iv) Elements of production record(s)

4113 21 CFR 530.12(e) Withdrawal, withholding, or discard time

4145 21 CFR 589.2000(e)(1) Use of clean-out procedures

4547 21 CFR 225.130 Cleanliness, inspection, cleanout

4557 21 CFR 225.158 Investigation and corrective action

1262 21 CFR 225.10(b)(2) Evaluation and supervision of employees

1389 21 CFR 530.11(a) Withdrawal period

1465 21 CFR 225.20(b)(1) Building grounds maintenance

1638 21 CFR 225.42(b)(5) Elements of receipt record

1760 21 CFR 225.42(b)(6) Lot number or shipment I.D. number

1765 21 CFR 225.42(b)(6)(i) - (v) Information required

1882 21 CFR 225.58(e) Subsequent production

1930 21 CFR 225.65(b)(3) Sequential production

2098 21 CFR 225.102(b)(4) Discrepancies investigated, reported

4111 21 CFR 530.12(c) Directions for use

4115 21 CFR 530.13(a) From bulk drugs

4552 21 CFR 225.142 Adequate procedures for Type A and Type B articles

1446 FDCA 402(a)(4) Hospital pen

1535 21 CFR 225.42(b)(2) Storage of packaged drugs

1792 21 CFR 225.42(b)(7) Discrepancies

1835 21 CFR 225.58(c) Assay results kept one year

1953 21 CFR 225.80(b)(2) Maintaining proofread label

2074 21 CFR 225.102(a) Lack of MRF

2232 21 CFR 225.115(b)(1) Maintaining records of complaints

2234 21 CFR 225.115(b)(2) Records of clinical and other experiences

4094 21 CFR 530.11(b) Use in animal feed

4099 21 CFR 530.20(a)(2)(ii) Extended withdrawal period

4118 21 CFR 530.13(b)(3) Outside of scope of professional practice

4131 21 CFR 589.2000(c)(1)(i) Renderers

4144 21 CFR 589.2000(e)(1) Separate equipment and facilities

4147 21 CFR 589.2000(e)(1) Written product separation procedures

4183 FDCA 501(a)(5) Frequency of administration

4548 21 CFR 225.130 Scales and metering devices

4553 21 CFR 225.142 Packaged Type A and Type B designated areas

4560 21 CFR 225.165 Establishment and use of adequate procedures

1447 FDCA 402(a)(4) Feeding areas

1457 FDCA 402(a)(4) Feeding colostrum

1464 21 CFR 225.20(b)(1) Adequate drainage

1482 21 CFR 225.30(b)(1) Capability to produce a medicated feed

1491 21 CFR 225.30(b)(2) Maintenance reasonably clean & orderly

1492 21 CFR 225.30(b)(3) Suitable for intended purpose

1510 21 CFR 225.35(b) Pesticide manufacture and storage

1634 21 CFR 225.42(b)(5) Receipt for each lot of drug received

1778 21 CFR 225.42(b)(8) Maintenance Time Requirement

1880 21 CFR 225.58(e) Distribution discontinued

1952 21 CFR 225.80(b)(2) Proofreading labels, labeling, placards

2091 21 CFR 225.102(b)(2) Preparation of Production Records

2140 21 CFR 225.102(b)(5) Identification which permits tracing history

2359 21 CFR 226.58(e) Test method reliability

2376 21 CFR 226.40(c) Equipment maintenance and operation

2658 21 CFR 226.102(b)(2) Records do not include

4098 21 CFR 530.20(a)(2)(i) Diagnosis and evaluation of conditions

4109 21 CFR 530.12(a) Name and address - drug dispensed by pharmacist

4110 21 CFR 530.12(b) Names of active ingredients

4112 21 CFR 530.12(d) Cautionary statements

4134 21 CFR 589.2000(c)(1)(ii) Maintaining records

4155 21 CFR 226.115 Appropriate action not taken

4157 21 CFR 225.42(b)(7) Detention of feeds with yield discrepancies

4158 21 CFR 225.80(b)(4) Label stock review

4453 21 CFR 225.10(b)(1) Employees lack understanding

4454 21 CFR 225.20(a) Facilities features

4542 21 CFR 225.102((a) Lack of Production Record(s)

4554 21 CFR 225.142 Bulk Type A and Type B storage

4555 21 CFR 225.142 Use in accord with directions

4558 21 CFR 225.158 Records kept for one year

4562 21 CFR 225.180 Assuring correct labels are used

4564 21 CFR 225.180 Bagged or bulk deliveries

4566 21 CFR 225.202 Elements of records

 4567 21 CFR 225.202 Facilitation of recall

13534 21 CFR 511.1(b)(7)(ii) Records: Maintenance

Long Desc

Treatment records were not [maintained] [complete]. Specifically,***

Causing a residue of an approved human or animal drug above an established safe level, safe concentration, or tolerance, through use of
the drug contrary to its labeling. Specifically, ***

You lack an adequate inventory system for determining the quantities of drugs used to medicate your [cows] [calves] [livestock]. Specifically,
***

Use of [a human] [an animal] drug in a manner contrary to label directions without benefit of a valid veterinary client-patient relationship.
Specifically, ***

Failure to systematically review treatment records prior to offering an animal for slaughter for human food, to assure that drugs have been
used only as directed and that appropriate withdrawal times have been observed. Specifically, ***

Failure to follow your veterinarian's prescription for [dosage] [frequency and duration of treatment] [route of administration] [species or class
of animal] [pre-slaughter withdrawal time] [special cautionary directions]. Specifically, ***

Causing an illegal residue in a food-producing animal of an approved human or animal drug through [prescribing the use of] [using] the drug
contrary to its labeling, and failing to take appropriate measures to assure that [assigned timeframes for withdrawal were met] [no illegal
residue would occur]. Specifically, ***

Expired drug(s) were observed in the drug storage area. Specifically, ***

Administration of an approved animal drug in excess of the indicated dosage, without benefit of a valid veterinarian-client-patient
relationship. Specifically, ***

Failure to [investigate] [implement corrective action] [maintain a record on the premises of corrective action] when assay results show
medicated feeds [not in accord with label specifications] [not within permissible assay limits]. Specifically,***

Failure to have a system to control administration of drug treatments to your animals. Specifically, ***

Periodic assays are not performed during the calendar year on at least three representative samples of medicated feeds requiring a
medicated feed mill license, for each drug or drug combination used. Specifically, ***

The Master Record File does not contain [the name of the medicated feed] [the name and weight percentage or measure of each drug or
drug combination and each nondrug ingredient to be used in manufacturing a stated weight of medicated feed] [a copy or description of the
label that will accompany the medicated feed] [manufacturing instructions or reference thereto that have been determined to yield a properly
mixed medicated feed of the specified formula for each medicated feed produced] [appropriate control directions including the collection of
samples for specified laboratory assays] [the basis for estimating quantity produced, where actual yield cannot be accurately determined
whenbatch
The finished feed is stored
production recordsinare
bulk].
not Specifically,
checked by a***responsible individual at the end of the working day to determine whether all required
production steps have been performed. Specifically, ***
Administration of an approved animal drug via a route, [oral] [intramuscular] [intravenous] [subcutaneous] [topical] [intramammary]
[intrauterine], which was not indicated in the labeling, without benefit of a valid veterinarian-client-patient relationship. Specifically, ***

Failure to properly [identify] [store] [handle] [control] drugs in the mixing areas to maintain their integrity and identity. Specifically, ***

The building is not constructed to minimize access by [rodents] [birds] [insects] [pests]. Specifically, ***

Failure to inquire about the medication status of the animal(s) that you [transported] [purchased] and delivered for [sale] [consignment] at
[an auction yard] [a slaughter plant]. Specifically, ***

Buildings are not maintained in a reasonably clean and orderly manner. Specifically, ***

All equipment that comes in contact with [active drug components] [feeds in process] [finished medicated feed] is not subject to all
reasonable and effective procedures to prevent unsafe contamination of manufactured feed. Specifically, ***

Medicated feed is not identified by appropriate labeling which provides the user with directions for use which if adhered to, will assure the
article is safe and effective for its intended purpose. Specifically, ***

A Master Record File providing the complete procedure for manufacturing a specific product is not [prepared] [checked] [dated] [signed or
initialed] by a qualified person. Specifically, ***

Failure to assure that the identity of a food-producing animal was maintained, where you had prescribed or dispensed an approved human
or animal drug contrary to the drug's labeling. Specifically, ***

Administration of a drug for conditions not [specified in its labeling] [prescribed]. Specifically, ***

Adequate procedures are not established for the [receipt] [storage] [inventory control] of all drugs to aid in assuring their identity, strength,
quality and purity when incorporated into products. Specifically, ***

Failure to [identify] [maintain records regarding the identity of] [record the existing identification of] the animal(s) that you [purchased]
[transported] and delivered for [sale] [consignment] at [an auction yard] [a slaughter plant]. Specifically, ***

Administration of an approved human or animal drug to a [species of animal] [class of animal] for which the drug was not labeled, without
benefit of a valid veterinarian-client-patient relationship. Specifically, ***

Failure to calibrate scales and metering devices [upon installation] [at least once a year after installation] [as frequently as necessary] to
insure their accuracy. Specifically, ***

A daily comparison is not made between the actual amount of drug used and the theoretical amount of drug to be used in terms of the
[semiprocessed] [intermediate] [finished] medicated feeds manufactured. Specifically, ***
Products that contain or may contain prohibited material fail to bear the caution statement, "Do not feed to cattle or other ruminants."
Specifically, ***

No assay was performed on the first batch for the calendar year of medicated feed requiring a medicated feed mill license. Specifically, ***

Receipt of materials that contain or may contain protein derived from mammalian tissues, and failure to maintain records sufficient to track
the materials throughout their receipt, processing, and distribution. Specifically, ***

Failure to maintain written clean-out procedures to prevent carryover of protein derived from mammalian tissues to animal protein or feeds
that may be used for ruminants. Specifically, ***

Buildings and grounds are not constructed and maintained in a manner to minimize vermin and pest infestation. Specifically, ***

Administration of an approved animal drug [more frequently] [for a longer time period] than specified in the labeling, without benefit of a valid
veterinarian-client-patient relationship. Specifically, ***

Failure to maintain a daily inventory record for each drug used in the manufacture of medicated feeds. Specifically, ***

Production record(s) fail to include [the product identification] [the date of production] [a written endorsement in the form of a signature or
initials by a responsible individual] [the quantity and name of drug components used] [the theoretical quantity of medicated feed to be
produced] [the actual quantity of the medicated feed produced] [an estimate of the quantity to be produced and stored in bulk, based on the
basis for the estimate in the MRF]. Specifically, ***

Failure to provide labeling containing [withdrawal] [withholding] [discard] time as specified by the veterinarian for a human or animal drug
prescribed for use in an animal contrary to the drug's labeling. Specifically, ***

Failure to use clean-out procedures or other means adequate to prevent carryover of protein derived from mammalian tissues to animal
protein or feeds that may be used for ruminants. Specifically, ***

Equipment for producing medicated feeds of intended potency and purity is not [maintained in a reasonably clean and orderly manner]
[designed, constructed, installed and maintained so as to facilitate inspection and use of cleanout procedures]. Specifically, ***

Results of laboratory assays of drug components indicated that medicated feed was not in accord with the permissible limits, and no
[investigation] [corrective action] was implemented immediately. Specifically, ***

Failure to provide an on-going program of evaluation and supervision of employees in the manufacture of medicated feeds. Specifically, ***

Administration of an approved animal drug contrary to the labeling, without benefit of a valid veterinarian-client-patient relationship, in that
pre-slaughter withdrawal time was not observed. Specifically, ***

The building grounds are not routinely maintained so that they are reasonably free from [litter, waste, and refuse] [uncut weeds and grass]
[improperly stored equipment]. Specifically, ***
Drug receipt records do not accurately indicate the [identity] [quantity] [name of the supplier] [supplier's lot number or other identifying
number] [date of receipt] [condition of the drug when received] [return of any damaged drugs] for each lot of drug received. Specifically, ***

The daily inventory records for drugs do not include [the manufacturer's lot number] [the feed manufacturer's shipment identification
number]. Specifically, ***

Daily inventory records for each drug used do not include [the quantity of drug on hand at the beginning and end of the work day] [the
amount of each drug used, sold, or otherwise disposed of] [the batches or production runs of medicated feed in which each drug was used]
[information concerning any semiprocessed intermediate mix to be used in a medicated feed] [the action taken to reconcile any
discrepancies in the inventory record]. Specifically, ***

Following distribution of a medicated feed which failed to meet its labeled drug potency, subsequent production of that feed was resumed
prior to the establishment of proper control procedures. Specifically, ***

Sequential production of medicated feeds is not done on a predetermined basis designed to prevent unsafe contamination of feeds with
residual drugs. Specifically, ***

When significant discrepancies were noted on the batch production records, there was a failure to [institute an investigation immediately]
[describe the corrective action taken on the production record]. Specifically, ***

Failure to provide labeling containing directions for use as specified by the veterinarian for a human or animal drug prescribed for use in an
animal contrary to the drug's labeling. Specifically, ***

Compounding an animal drug from a bulk drug. Specifically, ***

Adequate procedures are not [established] [maintained] for the [identification] [storage] [inventory control (receipt and use)] of all Type A
medicated articles and Type B medicated feeds intended for use in the manufacture of medicated feeds. Specifically, ***

Failure to [identify] [segregate] [quarantine] treated animals. Specifically, ***

Packaged drugs are not stored in their original closed containers. Specifically, ***

Failure to [investigate] [take corrective action for] a significant discrepancy between actual drug usage and theoretical drug usage.
Specifically, ***

Failure to maintain on the premises, originals or copies of all results of assays [including those from State feed control officials or any other
governmental agency] for a period of not less than one year after distribution of the medicated feed. Specifically, ***

Proofread labels are not [initialed and dated by a responsible individual] [kept for one year after all the labels from that batch have been
used]. Specifically, ***

Failure to have a Master Record File for manufacturing a specific product, which provides the complete procedure for manufacturing a
specific product. Specifically, ***
The original or copy of a record of each oral or written complaint received relating to the safety and effectiveness of the product produced is
not maintained on the premises. Specifically, ***

Failure to [maintain] [report] records and reports of clinical and other experience with medicated feeds whose manufacture requires a
medicated feed mill license. Specifically, ***

An approved drug was used in or on an animal feed in a manner not in accordance with the approved labeling. Specifically, ***

A substantially extended withdrawal period, supported by appropriate scientific information, was not established for the use of an approved
drug in a food-producing animal, in an extralabel manner. Specifically, ***

Compounding of an approved drug for use in an extralabel manner was not performed by a licensed [pharmacist] [veterinarian] within the
scope of a professional practice. Specifically, ***

Products that contain or may contain prohibited material fail to bear a label containing the caution statement, "Do not feed to cattle or other
ruminants." Specifically, ***

Failure to maintain separate [equipment] [facilities] for the manufacture, processing, or blending of protein derived from mammalian tissues,
to avoid commingling with or cross-contamination of products containing non-mammalian protein. Specifically, ***

Failure to maintain procedures for separating products which may contain protein derived from mammalian tissues from all other protein
products, from the time of receipt until the time of shipment. Specifically, ***

Administration of a drug [over a longer time period] [more frequently] than [specified in its labeling] [prescribed]. Specifically, ***

The [scales] [liquid metering devices] are not of suitable [size] [design] [construction] [precision] [accuracy] for their intended purpose.
Specifically, ***

The [packaged Type A medicated articles] [packaged Type B medicated feed] are not [stored in designated areas] [stored in their original
closed containers]. Specifically, ***

Adequate procedures are not [established] [used] for all equipment used in the production and distribution of medicated feeds to avoid
unsafe contamination of medicated [and nonmedicated] feeds. Specifically, ***

Failure to adequately clean feed and water containers to prevent cross-contamination of medicated and non-medicated feeds and liquids.
Specifically, ***

Feeding colostrum or milk from treated cows to calves intended for slaughter. Specifically, ***

The building grounds are not adequately drained so that they are free from standing water. Specifically, ***
Equipment does not possess the capability to produce a medicated feed of intended [potency] [safety] [purity]. Specifically, ***

Equipment is not maintained in a reasonably clean and orderly manner. Specifically, ***

Equipment is not of suitable [size] [design] [construction] [precision] [accuracy] for its intended purpose. Specifically, ***

Work areas and equipment used in the [manufacture] [storage] of medicated feeds or components thereof are not physically separated from
[work areas] [equipment used] for the [manufacture] [storage] of [fertilizers] [herbicides] [insecticides] [fungicides] [rodenticides] [pesticides].
Specifically, ***

Failure to [prepare] [maintain] a receipt record for each lot of drug received. Specifically, ***

Records are not maintained on the premises for at least one year after the complete use of a drug component of a specific manufacturer's
lot number or shipment identification number. Specifically, ***

Distribution of a medicated feed which failed to meet its labeled drug potency was not discontinued. Specifically, ***

Incoming [labels] [labeling] [placards] are not proofread upon receipt from the printer against the Master Record Files to verify suitability
and accuracy. Specifically, ***

The production record is not prepared by qualified personnel for each batch or run of medicated feed. Specifically, ***

Failure to have identification which permits the tracing of the complete and accurate manufacturing history of the product by the
manufacturer, including [an individual batch or production run number, code or date] [suitable identification applied to the label, package,
invoice or shipping document]. Specifically, ***

Laboratory controls do not include adequate provisions to check the [reliability] [accuracy] [precision] of laboratory test procedures.
Specifically, ***

Equipment is not [maintained] [operated] in a manner [to avoid contamination of Type A medicated articles] [to insure integrity of the finished
products]. Specifically, ***

The batch-production and control records do not include [records of each step in the manufacturing, packaging, labeling and controlling of
each batch] [dates] [specific identification of drug components used] [weights or measures of all components] [laboratory control results]
[mixing times] [endorsements of the individual actively performing or the individual actively supervising or checking each step in the
operation]. Specifically, ***

Failure to make a careful diagnosis and evaluation of the conditions for which an approved human or animal drug was to be used in a food-
producing animal, contrary to the drug's labeling. Specifically, ***

Failure to provide labeling showing the [name of the prescribing veterinarian] [name and address of the dispensing pharmacist] for a human
or animal drug prescribed for use in an animal contrary to the drug's labeling. Specifically, ***
Failure to provide labeling showing the established name of each active ingredient for a human or animal drug prescribed for use in an
animal contrary to the drug's labeling. Specifically, ***

Failure to provide labeling containing cautionary statements as specified by the veterinarian for a human or animal drug prescribed for use
in an animal contrary to the drug's labeling. Specifically, ***

Manufacture of products that contain or may contain protein derived from mammalian tissues, and failure to maintain records sufficient to
track the materials throughout their receipt, processing, and distribution. Specifically, ***

Appropriate action is not taken as a result of evaluation of complaints on Type A medicated articles. Specifically, ***

Medicated feeds implicated in drug inventory discrepancies based on a comparison of actual vs. theoretical usage are not detained until the
discrepancies have been reconciled. Specifically, ***

Label stock is not [reviewed periodically] [discarded when discontinued labels are found]. Specifically, ***

All employees involved in the manufacture of medicated feeds do not have an understanding of the [manufacturing or control operations
they perform] [location and proper use of equipment]. Specifically, ***

The features of the facility necessary for the proper manufacture of medicated feeds fail to provide for [ease of access to structures and
equipment for routine maintenance] [ease of cleaning of equipment and work areas] [facilities to promote personal hygiene] [structural
conditions for control of vermin and pests] [adequate space for the orderly receipt and storage of drugs and feed ingredients] [adequate
space for the controlled flow of materials through the processing and manufacturing operations] [equipment necessary for the accurate
packaging and delivery of a medicated feed of specified labeling and composition]. Specifically, ***
Failure to have production record(s) for specific products which include the complete history of each batch or production run. Specifically,
***

Bulk [Type A medicated articles] [Type B medicated feeds] are not identified and stored in a manner such that their identity, strength, quality
and purity will be maintained. Specifically, ***

All [Type A medicated articles] [Type B medicated feeds] are not used in accordance with their labeled mixing directions. Specifically, ***

Records of [investigation] [corrective action] with respect to assays of drug components not meeting permissible levels are not maintained
on the premises for a period of one year. Specifically, ***

Labels are not [received] [handled] [stored] in a manner that [prevents label mix-ups] [assures that the correct labels are used for the
medicated feed]. Specifically, ***

All deliveries of medicated feeds, whether bagged or in bulk, are not adequately labeled to assure that the feed can be properly used.
Specifically, ***

Formula, production and distribution records are not maintained identifying the [formulation] [date of mixing] [date of shipment (if not for own
use)]. Specifically, ***
The [formula] [production] [distribution] records are not adequate to facilitate the recall of specific batches of medicated feed that have been
distributed. Specifically, ***

Complete records of the investigation were not maintained. Specifically, ***

Frqncy

72

52

32

29

28

19

17

15

15

14

14

12

12

11
10

6
6

3
3

2
2

1
1

1
1

1
1