DEPARTMENT OF BEALm AND BUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

DISTRICTADDRESS ANO PHONE NUMBER

6/13/2017-6/29/2017*
19701 Fairchild
Irvine, CA 92612~2445 .....
~ ....
3012,228279
(949) 608-2900 Fax: (949) 608-4417

Nayan Patel , President and. Pha r macist- in- Charge

ARM NAl\AE .

Auro Pharmacies Inc 511 S Harbor Blvd Ste F

TYPE ESTABUSHM<NT INSPEClB>

La Habra, CA 90631 - 9375 outsourcing Faci lity

Th.is document lists observations made by the FDA representative(s) during the inspection ofyour facility. They are inspectional
observations, and do not' represent a final Agency deteJl!lination.regarding your compliance. If you have an.objection regard,ing an
observation, or have implemented, or plan to implement, corrective action in response to an observation, you may discuss the objection or
~ ..,;nn , .;; th th .. J;"n .!. • sI rlnnno the insnection or submit this mfonnation to FDA at the address above. If vou have anv
questions, please c.ontact FDA at the phone number and address above.

DURING AN INSPECTION OF YOUR FIRM I OBSERVED:

OBSERVATION 1
The responsibilities and procedures applicable to the quality control unit a(e· not fully followed.

Specifically, the quality control unit does not,take full responsibility in ensuring that sterile drug
products prepared by your firm .meet all the required specifications before release and that the firm's
operations follow established standard operating procedures or approved documents. For example,

A. Methylcobalamin 1 mg/mL injection lot 170214@1 was tested at a contract labf(o) (4i, with
active ingredient assay result·o f (b) <4>% which failed the sp~cification of[t>) (4) 1%. Even
through the. associated investigation memo (OOS OOOlo) concluded that the lot was placed into
quarantine and subsequently destroyed, the batch record was approved on 5/2/2017 for release
and the product batch was distribuied to customers.

B. Methylcobalamin 1 mg/mL injection lot 170310@1 was tested .at a contract lab, ~., with
active ingredient assay result ofCb> <41% which failed the specification of~DH4) %. No OOS
investigation was generated. The batch record was approved on 3/30/2017 for release and the
product bateh was distnbuted to customers.

C. According to your firm's PIC, DMSO 99.9% Infusion product is required by your firm to be
[5) (4 n sterilized vi (o) (4) ;. Fori(o) (4n lots ofDMSO product prepared in 2017
(17021 O@l, 170322@2, and 170504@2), although the lots were ~Df(4}1., none of the
associated batch records contained[(o) (4) I forms. These batch records were approved by QA
and the product lots were released without verifying the product sterilization status.

EMPl.OYEE(S) SIGNATURE .OATE ISSUED

SEE REVERSE Liming Zhang, I nvestigator 6/29/2017

OF THIS PAGE X UmingZl>aog

FORl\I FDA:483 (09/811) PREVIOUS 60fTION onSOl..£11!: INSPECTIONAL OBSERVATIONS PAGE 1OF 13PAGES
 • • •

DEPARTMENT OF HEALTH AND HUMAN SERv.ICES

FOOD AND DRUG ADMINISTRATION

DISTRICT SS.AND PHONE l'AJMBER DATE(S! ~ ~PoCTION

19701 Fairchild 6}13/2017-6/29/2017 *

FEI NUMeEft
Irvine, CA 92 612-2445
(949)608-2§00 Fax:(~49)608-4417 3012228279

Nayan Patel ., Presiden ~ and ·Pharmacist-in-Charge

FIR l'IAME ADDRESS

Auro Pharmacies Xnc 511 s :Harbor Blvd Ste F

La Habra, CA 90631-9315 outsourcing Facility

D. The (15) (4) forms and (15) (4) ,fonns ass_ociated with the s.terilization of;(o) (4)
_ _ _ and vatious parts requited for the preparation ofAscorbic Acid 500·rilg/mL injection
product lOt 170511@3 were ·included in th¢·batch record but were not approved. However, the
batch-record fot this lot was·approved and.the product lot was releaSed by QA.

ff The instructions .iil the master forinufation documents are not aligned with the actual
manufacturing practices docutnented·inJhe batch records. The product batch records were
approved by your fimi.' s quality unit without identifying such discrepancies. For example,
1. The DMSO 99.9% Infusion product master formulation sheet MF-SC-01.1049.0l , effective
8-Feb-17,:instructsto 15 4
...........~~---------------------......

The drug product preparation does not use this .type o (b) ('fl. Instead, a
15) 4) · is;used.
2. The DMSO 99.9% Infusion product master formulation sheet does not requirt:{5) (4)
sterilization, In practice,·the ~nished product is (o) (4) .
3.. The Amihosyi1 l 0% injection product master formulation sheet MF-SC-01.1148.01, effective ·
s.-May-17, requii:es the use of(5) 4) ·for (o) (4) In practice.(5 (4
preparation as per your .firm's Pharmacist-in-Charge.

F. Personnel engaged in' drug product preparation and supporting activities lack adequate training.
For example,
1. There is no training tecord established for anyone involved in: the receiVirig inspection of
· materials un:der SOP-GC-01.3000:01 Receiving and Inspection, effective 12'-Dec-16.
2. There is no training:record for anyone involved in product labeling operation that is:.govemed
by SOP-SC-01.11 ·59.0 I Labeling of»FiniShed Product,.effective 6-December-16.
3". Thei:eis no training-record foroperatorsp_erforming the vial and stopperwashing operation.
4. There is no·>trainingrecord established for operators perfoi:mirig 100% visual che.ck of the
unlabeled product Vials".

EMl't:OVEE(S)SIGN4TI.JllE DATE ISSuEO •·

SEE REVERSE Li ming Zhang, Investigator .,.,.,,, 6/29/2017

OF THIS PAGE X Uming 2hM19

FORM FDA 483 (09108) PREVIOUS EDmON OBSOtm'E INSPECTIONAL.OBSERVATIONS PAGE2 OF"13 PAGES
 DEPunmN'i OF HEALTH AND DUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

19701 Fairchild
El NUMBER
Irvine , CA 92612-2445
(949) 608-2900 Fax: (949) 608-4417 3012228279

Nayan Patel , Presidept and Pharmacist-in- Gharge

FIRM STREET ADORES

Auro Pharmacies Inc .51.1 S Harbor Blvd Ste F

RY·

La Habra, CA 90631-9375 Outsourcing Facili ty

G. SOP-SC-(ll.1100.01 Document Numbering System, effective 29-Jul-16, requires the use of

document change request (DCR) form FR-SC-02-1100.01 for creating new documents or
revisin existing documents and such OCR shall be reviewed and approved by QA. None of the
firm's SOPs initiation or revision used such DCR form.

H. SOP-SC-01.1145.01 Recall Policy Procedqre, effective 29-Jul,.16, requires the use of a(o) (4)
log to identify dispensed product. No such o 4 logs are used by the

OBSERVATION 2

The accuracy, sensitivity, specificity and reproducibility o.f test methods have no.t been established.

Specifically, the test methods used.to release your firm's sterile drug products are either not validated.o r
verified for their in_tended use. For example, ·

A. Your firm's sterile drug products are sent to a contract lab, (b) (4)., for assay-test. According to
(6}14 certificate of analysis, most of the assay test procedures are not validated. Your firm used
the testresults from these non-validated procedures to release drug products .

. B. The Methylcobalamiµ 1 mg/m.L injection product lot 170214@.l failed assay test at (b) (4) with a
non-validated HPLC procedure (OOS-00010). Your finn retested the product lot in-house with
an (5 4 instrument and released the product lot based o~ the passing results. This t) 4
in-house test method was not established and:not validated.

C. Your firm has conducted sterility, endotoxin, and particulate tests in-house to release the sterile
drug products since May 2017. None ofthese test methods used in-house have been validated or
verified.

OBSERVATION 3

E!<!l'l.OYEE(S) SIGN~TVRE . DATEISSUED

SEE REVERSE Liming Zhang, Investigator 6/29/2017

OF THIS PAGE x Liming Zhang

FOllM JIDA ~83 (09108) PREVIOUS liOITlQN OBSOLEIE INSPECI'IONAL OBSERVATIONS PAGE30F 13PAGES
 • • •

DEPARTMENT OF HEALTB AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

DA

19701 Fairchild 6/13/2017 - 6'/ 29/2017*

. FEINUlllBER
Irvine, CA 92612-2445
(949)608-2900 Fax : (949) 608-4417 3012'228279

NAME ANO TITLE.OF INOMOUAL TOW OM REPORt SSUED

Nayan Patel , President and Pharmacist-in--charge

Auro Pharmaci.es Inc. 511 s Harbor Blvd Ste· F

E ESTABLISHMENT INSPECTED

La Habra, CA 906.31 - 937 5 Outso~rcing Facility ·

Clothing of personnel engaged in the manufacturing and processing of drug products is not appropriate for the duties they
perform. ·

Specifically, the .gowning is not appropriate for the sterile filtration operation inside the clean room'Cbl <4Y.
For example, ·

A. On 6/1'3/2017 during a walk through inspection, (o) (4) operators were observed.with partially
exposed skin inside the ISO 7 dean room tt>n4J. The facial area around the eyes was not covered.
Even though operators used goggles to cover the skin around eyes when working·at the ISQ 5
LFH, the.goggles were put on wb~n operators were inside the ISO 7 room<b> c4 J_ The operators
were observed performing aseptic preparation of Magnesium Chloride drug product lot
170613@1 on that day, According fo ~e9tion 3.2.2.11 ofSOP-SC-01.1300.: 02 Gowning·and
Gowning Certification effective 16-Dec~l6, """
( 5...,..)-'(4
_,___ _ _ _ _ _ _ _ _ _ _ _ __
(o) (4)

B. The goggles used by operators during Magnesium Chloride drug product fot 17()613@1- aseptic
preparation on 6/13/2017 were not sterile; Section 3.2.7 ofSOP-SC.:·OI.1300~ 02 states" o 4

OBSERVATION 4
Procedures'designed to prevent microbiological contamination ofdrug products p'urportlng)o be sterile are not established
and followed.

Specifically, your .firm's aseptic preparation ofdrug producds not appropriate. For 'example;

During a walk through inspection on 6/13/2017,. an.operator was seen filling Magnesium Chlorid.e;drug
product lot l 70612@i (o) (4) inSide the ISO 5 LPN. The operator (o) (4)

EMPLOYEE(S) SIGNATURE DATE ISSUED

SEEA~EVERSE Liming Zhang_,, I nves,tiga.tor 6/29[ZOi7

OF THIS PAGE X Uming Zhoog·

FoRM1'J)A 4SJ (OMl8) INSPECTIONAL OBSERVATIONS . PAGE 4 op:13 PAGES

 DEPARTMENT OFHEALTH AND HUMAN SERVICES
FOOD.AND DRUG ADMINISTRATION
~''""""' """"'"ess ,...,.v n"""~''"""'BE R

19701 Fairchild 6/1 3/2017-6/29(20 17*

FEI NUMBER
Irvine, CA 92612~2 44 5
(949) 608- 2900 Fax : (949 ) 608-4417 3012228279

........,ANO TITLE Of' INDIVDUAL TO WnvM ="""TISSUED

Nayan Patel , Pres i dent and Pharmaci st- in- Char ge

FIRMNA.IAE STREETADDRESS

Au r o Pharmacies Inc .511 S Harbor Blvd Ste F

"'1'.STATE, ZIP \.vuc. COUNlRY.
La Habra, CA 90 631-9375 Outsourc i ng Facil ity

OBSERVATION 5
Procedures designed to prevent inicrobiological contamination of drug products putporting to be sterile do not include
adequate validation of the. sterilization process.

Specifically,

A. The .ISO 5 LFH certification performed in February 2017 did not include active air viable count
assessment.

B. The certification of all clean areas including ISO 5 LFHs and ISO 7 rooms performed in
February 2017 were performed only at the[D) (4~ condition.

C. Your firm does not perform active air monitoring during aseptic processing of drug product.

D. Your firm does not perform growth promotion tests for every batch ofmedia[(o) (4) that were
prepared in-house for environmental monitoring dU.ring sterile drug productpreparation to ensure
that the media used can support microbial gi;owth. For example,. the following batches oft6)l 41
media were not tested for growth promotiollJ(b) <4i ·
1. Lot 170206/20 and lot 170124/21 used for envirownental monitoring during the preparation
of Methylcobalamin 1 mg/min injection product lot 170214@1. The product·lot was
released on 5/2/2017.
2. Lot 170503 and lot 170424 used for environmental monitoring during the preparation of
Ascorbic Acid 500 mg/mL injection product lot 170511@3. The product lot was released on
5/26/2017.

OBSERVATION 6

EMPLOYEE(S) SIGN.<\TllRE 01\TEISWED

SEE REVERSE Liming Zhang, I nvest igat or 6/2 9/2 01 7

OF THIS PAGE X Uniog ZNng

FORM FDA 48.l (09/08) PREVIOVS EDITION OBSOLETE INSPECTION.Ai. OBSERVATIONS PAOE $ Of 13 PAGES
 •
•
•

DEPARTMENT OJ!'. HEALTH AND HUMAN SERVICES

FOOD :AND DRUG ADMINISTRATION
.ut.... · ~- __,_ss"'_, -r...... ~NUM8ER DAmS) Of INSPECTION

19701 Fairchild 6/13/2017-6/.29/2017*

Ft:IHUMSt:t<
Irvine, CA 92612-2445
(949)608-2900 Fax: {~49)608 -4417 3012228279
I

"""'"""'u " ' EOFINDlvwv"'- TOWHOM=1 ISSUal

Nayan Patel President and Pharmacist~in-Charge

FIRMNMtE
' Olt<t:t:I ADORESS

Auro Pharmacies Inc Q.11 s Ha.r bor Blvd Ste F

1..11 T, STATE, ZP CODE. CCUllTRY T -~-- 11,......--11;"' 111;1.1'

La Habra, CA 9063 1-93'75 Outsourcing Facility

Aseptic processing areas are deficient regarding the_system for cleaning and disinfecting the room and equipment to produce
aseptic conditions.

Specifically~ the cleaning practice used in your firm's·aseptic filling operation areas is not appropriate.
For example,

A,. No sporicidal agent is used in the clean rooms other than inSide the ISO 5 LFH.

B. The surface of equipment used for aseptic filling process inside ISO 5 LFH, such as peristaltic
pump, wa:s never cleaned with 'sporicidal agent.

C. According to section3.2 of SOP~SC-0 L1305.Q2 Cleaning ofSterile Compounding Fatility

effective 9-December.:16 "1(0) (4) · ·J
~I !.~· There.·areat least.3·instances shown below W,here the
Of(4) jcleaning on walls_and ceilings·was ilotperform~d. Sterile dru,g products were prepared
dllring these weeks. No deviation investigation _cir justification was.documented.
1. The week of 5/08/2017. The cleaning form was·approved.
2. The week of 5/IS/2017. The cleaning form_ was approved.
3. The week of 5/22/2017. The cleaning form. was not approved.
'

OBSERVATION 7

Aseptic processing areas are -deficient regarding the system for monitoring envhonmental conditions.

Specifically,

E. Your firm's-current environmentalmonitoring_program does not inelude any viable and non­
viable parti¢ulate monitormg.during aseptic filling of drug product.inside ISO 5 tFH.

F. Pressure differentials are monitored[(5) (4) I in the classified clean rooms., However sucli
pressure differentials are not monitored at the time during aseptic filling of drug products,

EMPlOYEE(S) SIGNATUl\E DATE ISSUED·

SEE REVERSE Liming Zhang_,. Investigator

.,,.,,.., 6/29/2,0i7

--­
OF THIS PAGE X Umin; Zh&119
-!19-t lifl U191iieD*'9~

.FO.R M FDA 43J (0?/08) PUVJOUS EDlJIONOBS.OLE'fE lNSPECTIONAL OBSERVATIO~S .PAOI'! 6 OJ'H P.AGES
 DEPARTMENT QF HEALTB AND HuMAN SERVICES
FOOD AND DRUG ADMINISTRATION
DISTRICT ADDRESS N<KJ f'HC)tjE NUMBER

19701 Fairchild 6/13/ 2017-6/29/2017*

F[JNUMBER
Irvine , CA 92614 - 2445
(949.) 608-2900 Fax : (949) 60 8-4417 3012228279

NAME ANO mLE OF INOMDUAI. TOW~ = ~T ISSuEu

Nayan Patel , President and Phar macist- in- Char ge

FIR'4NAl>O: ' " t<tt 1 ADORE""

Auro Pharmacies Inc 511 S Ha rbor Blvd Ste F

u . STATE. ZP OOCE. COUNTRY TYPE ESTABL,,,~ENT tlSr~ •<D

La Habra , CA 90631-9375 Outsourcing Faci lity

G. Your firmtakes!(O) (4) from the IS05 LFH[(o) (4}as part of the (b) (4) .EM
monitoring. No justification is established on why no other surface samples are taken from the
inner walls of the IS05 LFH.

H. Your firm has no justification for the alert and action limits established for environmental
monitoring. This deficiency was cited during the last FDA inspection. For example, alert and
action limits·for settling plates used during aseptic fillmg of drug product in ISO 5 LFH are set
incorrectly ai!ti><• CFU/Plate and HCFU/Plate respectively. During the following drug~roduct
preparations, the settling plates showed results that exceeded the required limit of,(b) @nfu
per plate. ·
1. 3 CFUs were detected from settling plate for Ascorbic Acid 500 mg/mL injection product lot
170511@2 prepare<l in ISO 5 LFH tb>l4Y. .
2. 1 CFU was detected from settling plate for Magnesium Chloride 200 mg/mL injection
product lot 170518@1 prepared in ISO 5 LF~· ·

I. Your firm has not performed trending and periodic evaluation of the environmental mo:njtoring
results. ·

OBSERVATION 8
The flow of drµg product containers and closures though the building is not designed to prevent contamination.

Specifically, the vials and stoppers used for your firm's sterile products are not cleaned appropriately
before being depyrogenated or sterilized. For example, ·

A. The vials were washed in.a non-classified room<bl C41. On 6/ 13/2017 during a walk through
inspection, t:he door to roorri<b><4 >'was widely open and employees working inside the roomCbl (4)
were seen wearing street shoes.

B. According to section 3.1 ofSOP-SC-01.1620.01 Vial Washer -40 H4 > ..._._~----

I effective 22­

EMPl.OYEE{S)SIGHA1'JRE OATEl~O

SEE REVERSE Liming Zhang, Investigat or - · 6/29/201 7

OF THIS PAGE x !Mning Zhong

FORM FDA 483 (09/08) PUVIOUS mmoNOBSOLETE INSPECTIONAL OBSERVATIONS PAGe 7 01' 13 PAO.ES
 • • -
DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMJNISTRATION .

197.01 Fairch.i)d 6/13/2017-6/29/2017*

Irvine, CA 92612-2445 u

(949} 608-2900 . Fax:: (949) 608-.4417 3012228279

Nayan Patel , President and. Pharmacist-in-charge

F NAME: s
Auro Pharmacies. Inc Sli s Harbor Blvd Ste· F
.Cl]Y, STATE, Zip CODE. CO TYPE ESTABLISHMENT INSPEC

La Habra, CA 90631-9375 O~tsourting Facility

August-16,.the wash machine requires (15) (4) ofair pressure and(5) (4) p-fi(b) (4J at the inlet.
However~ ittiff•· water was-used by yout firm to operate the wash machine for vials. Your firm's .
(b)l4) system has not been.operational yet at the time of this .inspecticm. Vials washed by this
.machine·are used for.all sterile drug products prepared by your·firni.

C, Accor.ding to your firm's.operator, (15) 4

,:.::~=----~---~-""""!"'~-----!-----
. However,-the entire vial washing.operation was ,not
---~~---=~~--c---~--=---
recorded even though:such operatic>n should be documented op. the form SOP.-FR-02.1620,01
Vial-Washer(l5 4) I .effective 22:-Aug-16. There is no evidence that the vials used
for drug product filling were washed and rinsed wi · 15 4 priorto being
(15)(4)

D .. According to your. firm's operator,ao (4

There is....n-o-.d~o~c-um
-e-.
n-te...,d--.e
-v-oide
-.._n_c_e_,£.-or- su_c___

h fiiialiCb) (4) ri.nse on washed

stoppers. The stoppers are used·for alI:firm's sterile drug pro.ducts.

OBSERVATION 9
testing and release of·drug product for distribution do not include·appropriate laboratory deteonination ofsatisfactory
conformance.to the final ·specifications prior.to release. ·

Specifically, your firm's 100% visual inspection of the finished drug product vials.isinadequate. For
example, ' .

A. There is no written procedme describing the process for 100% viSual inspection offilled drug
product vials. This deficiency was cited from .the last FDA inspection.

B. On 6il3/2017 during a walk tlri-ough inspection at the proCluctlabeling-room, an -Qperator was

seenperfonning visual·inspection ofthe filled AminoSyn 10% drug prodUct lot 170523@2 by
(15) (4) ·to inspection. There·is no documented tnfrning record for this·
operator on the 100% visual drug product inspection. This deficiency was cited from the last
FDA inspection. ·

EMPl.OVES(S) SJGNATURE .DATE ISSUED

SEE-REVERSE L'iming Zhang, Investigator .,,.,..,, 6/29/2017

OFTHIS 'PAGE X urning Zhan9

FORM FDA 48J (09/08) ~SPECTIONAL OBSERVATIONS l'AOE 8 OFlHAGES

 DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

..,,. , ,...,i" AOOR...,.""" P,......c NUMBER DATCIS) OF l""r=.11vN.

19701 Fairchild 6/13/2017-6/29/2017*

Irvine, CA 92612-2445

· (949)608 - 2900 Fax: (949)608-4 417 3012228279

NAME ANDTITlE OF INOIV!OUAI. TO WHOM REPORT ISSUEO

Nayan Patel , President and Pharmacist-in-Charge

Auro Pharmacies Inc 511 s Harbor Blvd .S te F

CITY, STATE. ZIP CODE. COUNTRY· ,orE ESTABLISHMENT INSPECTED

La Habra, CA 90631-9375 Outsourcing Faci l ity

C. According to the batch.records, your firm did not perform 100% visual inspection of the filled
· clrno ' vi!'lic: The fii:>lcl fnr 100% visual insoection of finished dru2 product vials were
either marked NIA or the field·is not available from the master batch record. For example, the
following drug product batch reeords showed that the I 00% visual inspection ofthe filled drug
product vials were not performed and the batches were released.
• Ascorbic Acid 500 mg/mL injection lot 170505@1 released on 5/23/2017.
• Ascorbic Acid 500 mg/mL injection lot 170511@2 released on ·5/26/2017.
• Ascorbic Acid 500 mg/mL injection lot 1705 11@3 released on 5/26/2017.
• Glutathione 200 mg/mL injection 1.ot.170526@1 released on 6/9/2017.
• DMSO 99.9% infusion lot 170210@1 released on 3/10/2017.

OBSERVATION 10

Written.records are not always made ofinvestigations into unexplained discrepancies and the failure of a batch or any. of its

components to meet specifications. ·

Specifically, your firm failed to initiate OOS investigations into EM failures associated with drug
product preparation or failed to conduct thorough investigations to understand the root causes ofsome of
the product testing result failures. For example,

A .. Your firm failed to conduct thorough investigations on the product assay failures associated with
the finished products,
l. The assay result ofProcaineHCl 10 gm/mL injection product lot 170131@1 was reported a:s
r~1o which exceeded the specification [o} (4}1% and the failure result was confirmed by
the contract testing lab,(b) (4) as shown in OOSreport 0003. No detailed manufacturing
investigation was earned out to identify the possible root causes. The lot was destroyed.
2. The assay result ofGlutamine 30 mg/mL injection product lot 170221@2 was reported !lS
!tiH•1% which failed the specification ft>} (4n % as shown in OOS report 0007. No detailed
manufacturing investigation was carried out to identify the possible root causes. A
theoretical explanation with respect to the moisture content of the API was provided for the

EMPLO\'EE(S) SIGAATURE DATE ISSUED

SEE REVERSE Liming Zhang, Investi gator 6/29/2017
OF THIS PAGE X liming Zh•ng

. FORM FDA 0 3 (09/llSJ PREVIOUS BDIJl()N OBSOLETE INSPEC110NAL OBSERVATIONS PAGE 9 OF 13 PAGES
• • •

DEPARTMENT OF BEALTIJ AND HUMAN SERVICES

FOC>D::AND DRUG ADMmIS1RATION

,DfSTRICT AOORESSAND PHONE N<NBER '-"'• c(S)OF INS".'""'"vN

197.0 1 Fairchild 6./13/2017-6/29/2017*

Irvine, CA 92612-2445 FEI NII""''"'
(949)608- 2900 Fax: ( ~4 9)608-4417 3012228279

NAME ANO TITLE vr IM:>IVIUUAL TO Wl10M REPORT ISSUED

Nayan Patel , President and Pharmacist-in-Charge

STREET AOORESS

Auro Pharmacies Inc 511 S Harbor Blvd Ste F'

La Habra, CA 90631 ~ 9315 Outsourcing Facility

failure. However, such explanation was not justified as all Glutamine 30 mgl.inL injection
productbatches use the same APL The lot was destroyed.
3. The·assay reslilt of Glutathione 200 mg/mL injectionlot 170208@1 was re~orted as ~>:!j%
which failed the specification [(5) (4) % as shown in OOS report .0008. No detailed
manufacturing investigation was carried out to .identify the possible root caµses. A
theoretical explanation with respect to the moisture content ofthe API was provided for the
failure. However, such,explanation was not justified as all Glutathione 200 mg/~ injection
product batches·use the sam.e API. The lot was destroyed, ·
4. According to OOS rej:)Or:t 00010;,the assay results ofMethylcobalamin 1 mg/mL inj~ction
lotl 70214@1 and the MICB12B6 product lot f70204@1 failed'specification$ as shown
'belOw. No·manufacturing ill:v:estigationwas conducted to identify the .possible:root causes .
. The investigation.memo attributed the:failure results to the test procedure bias.due to the
presence Rt:>H4> 1.. However, no corrective action was taken to addiess this .
possible root cause. · ·
• For Methylcobalamin I mg/niL lot 170214@1, the assay resiilt wa.s tb><4>%against the
specificatioi:J(O} (4) I
• ForMIC B12 B6 prod:uet1ot 170204@1, the assay results are shown: below:
~ Methfonine (L): (b) (4)% against specification(5) (4)n1%
- Pyridoxine JICl Kb) (4)1%·against.·specificatioli [{!:>_) 4) %
- Methylcobalamiil: tbH4l% againSt specification[6) (4) %

B. Ybur firm fa'.iled to investigate action levei excursion involving environmental monitoring

results, ·

L The. settling plate .sampled from ISO 5 LFH (b) (4) on Sill/2017 ·showed3 CFUs during
preparation of Ascorbic Acid .500 mg injecticmprodUctlot 170511@2 by operatorr<b> <6r The 1•

batch was released on· 5/26/201T.

2. The settling plate ·sampled from 1805 LFH~b) (4} on 5/18/2017·showed l CFU during
preparation ofMagnesiUrii.. Chlorid~ 200 nig/inL ~jectiop. pro'ducflot 170518@1 by operator
r><6f. The·batch was,released on-6/2/2017.

E-.i:>YEE<S) SIGNAT\IRE DATE ISSUED

SEE.REVERSE ·Liming Zhang , Investigator .......,

6/29'/2017
OF THIS PAGE X liming.zho"!I

FORM FDA'OJ (09/08) INSPECTIONAL OBSERVATIONS. PAGE IOOF 13

PAGES
• • -
DEPARTI\1VfT OF HE4LTH AND.BUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
OIS11QCT ADu~SMD PHOOe.truMBJ:ll OATE(S).OF IN~TIOll

19701 Fairchild 6/ 1 3/201 7-6/29/2017*

f£(NUM8EH
Irvine , CA 92612 - 2445
(94 9 ) 608-2900 Fax: (94 9) 608-4417 301 2228279
'
NAME ANOTITLE OF IN DMOUAL TOWljOM REPOKT ISSUED

Nayan Patel ., Presictent and Pharmacist- in-Char ge

FIRM NAME ~I R""'""""~s

Auro Phar macies Inc SU s Harbor Blvd Ste F

CITY. STATE, ZIP. CODE, ...vuNTRY· - -­ ...._ISnr.:;n IN..,,..cv ED.

La Habra, CA 906.31- 9375 Outsourc':ing Facilit y

3. The mici'obi;tl surface sample taken1for room<b><41 (ISO 8[(15) (4) I

·ISO 7 room (b}C4l on 4/28/2017 showed TNTC·. The following four products were filled on
4/28/2017 ~nd all these folJf product batches were released.
• Methylcobalamin 10 mg/mL injection lot 170427@1 released on 5/16/2017.
• Calcium Chloride I00 mg/mL injection lot 170428@1 released on 5/ 16/2.0 l.7.
·• Methylte~ydrofolate 5 mg/mL injection lot 170427@3relel').se4 on5/16/2017.
• Phosphatidylcholine 35 mg/mL injectionJot 170427@2 released5 on·5/ 18/2017. ·
4. The microbial surface ~sample take from ISO 5 LFH 0502 in roo:m I ll'•l on 3/1/2017 .showed
31 CPUs. Even through no product was prepared in LFH (b}l4) on that day~. no OOS
investigation was initiated to·find root cause.

C. Your firm failed to use the proper OOS.investigation form FR-SC:-02.138]. Ol Out of
Specification Monitoring Report effective 13-Dec-16 that is required by.the SOP-sc~o 1.1380.0I
Out of Specification Investigations effective 13.:.D~c-l 6 to carry out the OOS inyestigations.

'
OBSER,VATION 11
Investigati!'ns of an unexplained discrepancy and a failure of a.batch or any of its ccimponents·lo meet any of its
specifica~ions did not .extend to other batches of the·same drug product and other drug products that may have l?een
associated with the spepific failure·or discrepancy.

Specifically, the investig~tion doCUD;lente<;l in :NCR-17'"0020 for Methylcobalamin 2 mg(mL injection

prodj.ict lot 170501@2 recognized thatthe as~ay test'pr0.cedure for the.product used.by the contract lab,
(b) (4) , was not validated. However~ the investigation failed.to extend the evaluation of assay test
procedures used by (b} (4) to your firm: ' s other dnJS. products. lt appeared that most ofthe ass~y test
procedures used by (b) (4) on the:frrm's finished drug;prqducts were not validated as shown on ~15Jl.il ~
certificate.of anitlyses. No c;orre.c;tive actions ba:v:e been.·taken by y our firm to address this deficiency at
the tiine of th•s inspection.

SEE REVERSE
EMPLDYEE(S) SIGNATURE
Liming Zhang , I nvestigator
- OATEISSIJEO
6/2 9/2017
OF THIS PAGE

FORM FDA 4113 (09108)

PAGES
PRBVJOUS EOlTION OBSOLllJB INSPECTIONAL OBSERVATIONS
---·
x Liming Zhang
$lglNl-- ~ 0....,<S

PAGE ll OF 13
 I •

DEPARTMENT OF HEALTH AND HUl\IAN SERVICES

FOOD AND DRUG ADMINISTRATION

asT""-'1 ADDRESS""'° PHONE NUMBER OAT'E(S) Of INSPECTION.

19701 Fairchild 6/13/2017-6/29/2017*

I rvi ne, CA 92612-2445 fEINUMSER

(949)608-2900 Fax: (949)608-4417 3012228279

NAMEAND TITLE OF INDIVIDUAL TOWHOM REPORT ISSUED

Nayan Patel , President and Pharmacist-in-Charge

Auro Pharmacies Inc 511 S Harbor Blvd Ste F

"'' , STATE, "PCvuc. COUl'f "", TYPE c-. fAllUSHMENT ,,..,,"'- o ~

La Habra, CA 90631-9375 Outsourcing Faci l ity

OBSERVATION 12

Results of. stability testing \ are

not used in determining expiration
.
dates.

Soecificallv. the shelf life of your firm's products is not supported by stability studies. For example,

A. All sterile drug products prepared by your firm are assigned a 6 month shelf life. There is no
stability study carried out on each drug product to demonstrate that the products can maintain
their identity, strength, quality, and purity at the end ofthe shelf life.

B. Thetbflifl, on-going product stability studies for Ascorbic Acid 500 mg/mL injection with
preservative and Glutathione 200 mg/mL .injection without preservative are deficient in that
1. These studies were initiated without approved stability study protocols.
2. The studies did not follow the written study protocols with respect to storage conditions and
test frequency.
3. The analytical methods used for the stability studies at contract lab, (b) (4 l.,' are not validated to
demonstrate that they are stability indicating.

OBSERVATION 13
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, sampling plans
and.test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and
purity.

Specifically,

A. The preservative content in your sterile drug products was not detennined .as part ofproduct
release testing.

B. You have not demonstrated the effectiveness of the antimicrobial preservative ingredient used in
your sterile drug products. According to section 3.2 ofSOP-SC-01.1340.01 Antimicrobial
Effectiveness Testing, effective 29-Jul-16J 5Jlll) I

EMPLOYEEIS)SIGNATURE o.t.~ISSUED

SEE REVERSE Liming Zhang, Investigator ''"'''"' 6/29/2017

OF THIS PAGE

FORM FDA 483 (09/08) PIUMOIJS EDmON 08SOLBIB INSPECTIONAL OBSERVATIONS

--
Xliming Zhang

PAOll J20F!3
PAGES
 DEPARTMENT OF HEALTH AND 'HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

.,., ,~v, AUµt<"'°S M«J PHO«E NUMBER OA1q~10FIN<>r=-TI01'{

19701 Fairchild 6/13/2017-6/29/2017*

FeNU"18ER
Irvine, CA 92612-2445
'(949) 608-2900 Fax : (949) 608-4417 3012228279

NAME """"· " LE Of IIDMOUALTO WHOM "°"""T ISSUED

Nayan Patel President and Pharmacist-in-Charge

..RM NAME ' s1~eer~~

Auro Pharmacies Inc 511 S Harbor Blvd Ste F

"'''· STATE. Zl'u.uc. wuNTfO" T'tPE ESTABl.ISnNcnT INSP.., ED

La Habra, CA 90631-9375 Outsourci ng Facil i ty

~0)(4) I
b)(4) I

*DATES OF INSPECTION
6/ 13/2017(Tue),6/14/2017(Wed),6/15/2017(Thu),6/16/2017(Fri),6/21/2017(Wed),6/22/2017(Thu),6/29/2017(Thu)

..

EUPLO\'EE(S) SIGNATURE DATE ISSl.IED

SEE REVERSE Liming Zhang, I nvestigator ''""'" 6/29/2017

OF THIS PAGE
----
x Liming Zhang
~'t'; 'lA'1111!1g a.,-s

FORlll FDA 483 (09/03) . PREVIOUS EDrTION OBSOU!TE INSPECTIONAL OBSERVATIONS PAGEUOF13
PAGES