FDA Nestle Purina Violations

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Nestle Purina PetCare 1/2/15
Public Health Service

Department of Health and Human Services
Food and Drug
Administration
US Custom House, Room
900
200 Chestnut Street
Philadelphia, PA 19106
215-597-4390
WARNING LETTER
15-PHI-06
January 2, 2015
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UPS OVERNIGHT DELIVERY
RETURN RECEIPT REQUESTED
Jason S. Christoffersen, Plant Manager

Nestle Purina PetCare
2050 Pope Road
Allentown, PA 18104-9308
Dear Mr. Christoffersen:
The Food and Drug Administration (FDA) conducted an inspection of your low-acid
canned food (LACF) manufacturing facility located at 2050 Pope Road, Allentown, PA,
from September 15, 2014 through October 1, 2014. The inspection revealed that your
firm manufactures a variety of low-acid dog and cat foods. The inspection also revealed
that your facility has significant deviations from the LACF regulations, Title 21, Code of
Federal Regulations, Parts 108 and 113 (21 CFR Parts 108 and 113).
As a manufacturer of low-acid canned food products, you are required to comply with the
Federal Food, Drug, and Cosmetic Act (the Act) and the federal regulations relating to
the processing of low-acid canned food products. These regulations are described in 21
CFR 108, Emergency Permit Control, and 21 CFR 113, Thermally Processed Low-Acid
Foods Packaged in Hermetically Sealed Containers. The Emergency Permit Control
regulations were issued, in part, pursuant to Section 404 of the Act, Emergency Permit
Control, 21 United States Code (USC) § 344. A temporary emergency permit may be
required for low-acid canned foods whenever a processor has failed to fulfill the
requirements of 21 CFR 108.35, including registration and filing of process information,
and the mandatory requirements in 21 CFR Part 113.
Based upon certain criteria in 21 CFR 113, low acid foods may be adulterated within the
meaning of section 402(a)(4), [21 USC § 342(a)(4)] in that they have been prepared,
packed, or held under insanitary conditions whereby they may have become
contaminated with filth, or whereby they may have been rendered injurious to health. You
can find the Act and the low-acid food regulations through links on FDA’s Internet home
page at www.fda.gov.
We acknowledge receipt of your October 15, 2014, written response to the FDA Form-
483, Inspectional Observations, issued to your firm on October 1, 2014. Our comments
regarding the adequacy of the actions you took to correct the objectionable conditions
and practices observed during the inspection are detailed after each violation that is
noted below.
The significant violations are as follows:
1. Your firm failed to process each low-acid canned food in conformity with at least the
scheduled process filed with FDA, as required by 21 CFR 108.35(c)(3)(i). Specifically,
Your firm’s filed scheduled process (SID # (b)(4)) for Alpo Chop House Rotisserie
Chicken flavor in Gourmet Gravy includes (b)(4) different process times for (b)(4)
different minimum initial temperatures (IT) of (b)(4) at a minimum sterilization
temperature of (b)(4). The process specified for a minimum IT of (b)(4) is (b)(4) at
(b)(4) with a minimum IT of (b)(4) and (b)(4) at (b)(4) with a minimum IT of
(b)(4). However, on March 14, 2014, the Daily Process Record - (b)(4) identified a
recorded IT of (b)(4) with a recorded cook time of (b)(4) for Lot (b)(4). This is less
than the filed process of (b)(4) required for the recorded IT of (b)(4). Further,
comments on this processing record state (b)(4) Low IT (b)(4) QA NOTIFIeD (b)(4)
Cook satisfied…” The critical factor of process time filed with FDA must reflect the
actual time required for delivery of the scheduled process.
We acknowledge that your written response states that your (b)(4) Thermal Process
Authority evaluated this process deviation and stated that this product received a
sufficient thermal process to achieve commercial sterility. Further, your response states
that this instance and actions taken were recorded in a deviation log, on October 3,
2014. Additionally, the response states that, in the future, process deviations will be
documented. We do not consider this response acceptable because your firm did not
provide documentation associated with the evaluation of the entire lot of product affected
by the process deviation and did not provide documentation and/or the specifics of your
corrective action plan in order to ensure that your firm will prevent these occurrences in
the future.
Your firm’s filed scheduled process (SID #(b)(4)) for FCC Mariner’s Catch 5.5oz. cans
and FCC Mixed Grill, 5.5oz. cans for the (b)(4) Retort ((b)(4)) lists critical factors that
require the in-feed leg to be at (b)(4), the steam dome (b)(4), and exit leg at
(b)(4). However,
o On February 25, 2014, FCC Mariner’s Catch temperature chart in-feed leg (top)
fell below the required (b)(4) to approximately (b)(4), to approximately (b)(4), and
to approximately (b)(4). Further, handwritten on the temperature chart is: “(b)(4)
Both chain (b)(4)…” and “Both chains down (b)(4)…Both chains down (b)(4)…”
Additionally, your firm failed to document indications of a temperature drop at
either time on the (b)(4) Retort Daily Process Record.
o On March 25, 2014, FCC Mixed Grill temperature chart in-feed leg (top) fell
below the required (b)(4) to approximately (b)(4). Further, handwritten on the
temperature chart is: “(b)(4) Both chain shut off (b)(4)…” Additionally, your firm
failed to document indications of a temperature drop on the (b)(4) Retort Daily
Process Record.
Authority evaluated these process deviations and stated that the products received a
sufficient thermal process to achieve commercial sterility. Further, your response states
that these instances and actions taken were recorded in a deviation log, on September
19, 2014. We do not consider this response acceptable because you did not provide
specifics of your corrective action plan in order to insure that your firm will prevent these
occurrences in the future.
Your firm’s filed scheduled process for formulated pet food chunks in gravy style (SID
#(b)(4)) lists a critical factor of (b)(4) as a pouch thickness for the (b)(4) retort. On
September 18, 2014, during the loading of Friskies Gravy Sensations with Turkey and
Giblets in Gravy into crates, our investigators observed (b)(4) pouches stacked on top
of each other entering the retort. Our investigators then obtained (b)(4)previously
processed pouches of Friskies Gravy Sensation with Turkey and Giblets in Gravy, Lot
#(b)(4), and measured the pouch thickness, which ranged from (b)(4). These
processed pouches were from the same production batch as the ones observed
entering the retort.
Additionally, pouch thickness is a critical factor for this filed process, and your firm failed
to monitor or document pouch thickness as required by 21 CFR 113.100(a). For
example, our review of the batch records for Friskies Gravy Sensations with Turkey and
Giblets in Gravy 3 oz. pouch processed on March 20, 2014 (Lot #(b)(4)) revealed that
pouch thickness was not monitored or documented. This observation was previously
discussed with your firm during the FDA inspection in 2007.
Authority evaluated this process deviation on October 8, 2014 and confirmed that the
products received a sufficient thermal process to achieve commercial sterility. Further,
your response states that this instance and actions taken were recorded in a deviation
log, on October 8, 2014. In addition, your response states that, within the next (b)(4), your
processing authority will file the revised SID to ensure the stack height critical factor
accounts for the pouch placement process variation noted in this observation. Your
response failed to state whether your firm plans to discontinue manufacturing this product
until your process authority files the revised process.
2. Your firm failed to identify, from a processor check or otherwise, deviations from the
scheduled process of critical factors which are out of control and failed to record these
deviations in a separate log, as required by 21 CFR 113.89. Specifically, for the
instances identified above in item #1, your firm failed to identify deviations from your filed
scheduled processes and critical factors. In addition, these process deviations were not
recorded in a separate file or log that details both the deviations and actions taken.
Authority evaluated these process deviations and determined that the products received
a sufficient thermal process to achieve commercial sterility and that these instances and
actions taken were recorded in a deviation log, as stated in item #1 above. Further, your
response states that the HACCP Corrective Action Plan will be reviewed and revised by
October 31, 2014. We do not consider this response acceptable because you did not
provide specifics of your corrective action plan in order to insure that your firm will
prevent these occurrences in the future.
3. Your firm failed to chlorinate or otherwise sanitize cooling water as necessary for
cooling canals and re-circulated water supplies, as required by 21 CFR 113.60(b).
Specifically, on September 16, 2014, our investigators observed that you failed to
sanitize the cooling cushion water that is re-circulated in your (b)(4) Retort System during
the processing of Friskies Supreme Supper, Lot #(b)(4), in your (b)(4) Retort System.
We acknowledge that your written response states that your firm is actively working with
your chemical supplier representative to achieve and implement a solution within the next
ninety (90) days. We do not consider this response acceptable because you did not
4. Your firm failed to establish a system for product traffic control in the retort room to
prevent un-retorted product from bypassing the retort process, as required by 21 CFR
113.87(b). Specifically, we observed that your can conveyors and the reject chute do not
have adequate protection in place to prevent an unprocessed can from falling into the
cooling canal in the case of a can jam or other equipment malfunction in your (b)(4)
Retort System. This observation was a discussion point during our November 7, 2007
inspection.
We acknowledge that you informed our investigators that you are in the process of
structuring a cover to prevent unprocessed cans from falling into the cooling
canal. Additionally, your written response states that you shared this plan with our
investigators and that this plan will be completed within the next (b)(4). We do not
consider this response acceptable because you did not provide specifics of your
corrective action plan in order to insure that your firm will prevent these occurrences in
the future.
5. Your firm failed to install the mercury-in-glass (MIG) thermometers in a location where
they can be accurately and easily read, as required by 21 CFR
113.40(a)(1)(v). Specifically, the angle of installation and the location of the permanent
ladder system on the (b)(4) and (b)(4) rendered the MIGs unreadable by our
investigators. Further, during the inspection, your Corporate Quality Assurance Division
Manager attempted to read these MIGs, and he could not provide an exact reading
during the inspection.
We acknowledge that during the inspection it was stated that the firm was confident that
the trained (b)(4) Retort Operators could accurately read these MIGs and that your written
response states that a plan will be developed with your (b)(4) Thermal Process Authority
to begin transitioning to alternate Temperature Indicating Devices (aTIDs) for the (b)(4)
Retorts in 2015. We do not consider this response acceptable because you did not
6. The records of all processing and production records were not signed or initialed by
a representative of plant management who is qualified by suitable training or experience,
as required by 21 CFR 113.100(b). Specifically, processing records, production records,
and recording temperature charts for various products were stamped with a rubber
stamp that read QA REVIEWED, date reviewed, and the name of QA reviewer. The
responsible QA reviewer did not initial or sign the records reviewed. The following
products, lot codes, and dates were associated with these records, as follows:
(b)(4) Retort System:

(b)(4):
Alpo Chop House Originals Roasted Chicken, Lot (b)(4)
Friskies Indoor Chicken, Lot (b)(4)
Mighty Dog Chicken Egg & Bacon Country Platter, Lot (b)(4)
Mighty Dog Chicken & Smoked Bacon Combo, Lot (b)(4)
Alpo Chop House Originals Filet Mignon, Lot (b)(4)
Mighty Dog Lamb and Rice, Lot (b)(4)
(b)(4):
Friskies Mixed Grill, Lot (b)(4)
ProPlan Senior Beef and Rice Entrée, Lot (b)(4)
Friskies Salmon Dinner, Lot (b)(4)
(b)(4): Alpo Chop House Rotisserie Chicken in Gravy, Lot (b)(4)
(b)(4): Alpo Prime Cuts with Beef, Lot (b)(4)
Alpo Chop House Originals Filet Mignon, Lot (b)(4)
(b)(4): Gravy Sensations with Turkey and Giblets in Gravy, Lot (b)(4)
This letter is not intended to be an all-inclusive list of violations. It is your responsibility to

ensure that all of your products comply with the Act, the low-acid canned food regulation
(21 CFR 108 and 113), the Current Good Manufacturing Practice regulation (21 CFR
110), and other applicable regulations. You should take prompt action to correct the
violations described in this letter and establish and implement procedures which will
prevent them from occurring in the future. Failure to take appropriate corrective action
may subject your firm and products to further actions, such as emergency permit control,
injunction, or seizure.
You should notify this office, in writing, describing the corrective actions that you will take
to bring your firm into compliance within fifteen (15) working days of receiving this
letter. Your response should include each corrective action that you have or will take to
correct these violations and, in particular, what methods and controls you will implement
to prevent their recurrence. Please include copies of any documentation that
demonstrates the corrections have been implemented. If corrective actions cannot be
completed within fifteen (15) working days of receiving this letter, please state the reason
for the delay and the time frame in which they will be completed.
Section 743 of the Act, 21 U.S.C. § 379j-31, authorizes FDA to assess and collect fees
to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-
inspection is one or more inspections conducted subsequent to an inspection that
identified non-compliance materially related to a food safety requirement of the Act,
specifically to determine whether compliance has been achieved. Re-inspection-related
costs means all expenses, including administrative expenses incurred in connection with
FDA’s arranging, conducting, and evaluating the results of the re-inspection and
assessing and collecting the re-inspection fees, 21 U.S.C. § 379j-31(a)(2)(B). For a
domestic facility, FDA will assess and collect fees for re-inspection-related costs from
the responsible party for the domestic facility. The inspection noted in this letter
identified non-compliance materially related to a food safety requirement of the Act.
Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Your written response should be sent to Lynn S. Bonner, Compliance Officer, at the
address noted above. If you have any questions concerning this letter, please contact
Compliance Officer Bonner at 215-717-3074 or by e-mail at Lynn.Bonner@fda.hhs.gov.
Sincerely,
/S/
Anne E. Johnson
Acting District Director
Philadelphia District
cc:
Mr. W. Patrick McGinnis
President and CEO
Nestle Purina Petcare
801 Chouteau Avenue
St. Louis, MO 63102
Mr. John Bear

Vice President and Director of Manufacturing
Nestle Purina Petcare
801 Chouteau Avenue
St. Louis, Missouri 63102
Pennsylvania State Department of Agriculture

Bureau of Food Safety and Laboratory Services
2301 North Cameron Street
Harrisburg, PA 17110-9408
Attention: Dr. Lydia Johnson, Director, Food Safety Division
Page Last Updated: 01/13/2015

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 U.S.

Food and Drug Administration Search FDA 

Home  Inspections, Compliance, Enforcement, and Criminal Investigations 

Nestle Purina PetCare 1/2/15

Public Health Service

Jason S. Christoffersen, Plant Manager

Dear Mr. Christoffersen:

The significant violations are as follows:

(b)(4) Retort System:

This letter is not intended to be an all-inclusive list of violations. It is your responsibility to

Mr. John Bear

Pennsylvania State Department of Agriculture

Page Last Updated: 01/13/2015

U.S. Food and Drug Administration

Combination Products  International Programs  Consumers

 Advisory Committees  News & Events  Health Professionals

 Regulatory Information  Training & Continuing Education  Science & Research

 Safety  Inspections & Compliance  Industry

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