Product: Animal & Veterinary

Recipient: Nestle Purina PetCare United States Issuing Office: Philadelphia District Office United States

Department of Health and Human Services Public Health Service

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

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.

We acknowledge that your written response states that your (b)(4) Thermal Process 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.

We acknowledge that your written response states that your (b)(4) Thermal Process 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 devi ations 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.

We acknowledge that your written response states that your (b)(4) Thermal Process 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 provide specifics of your corrective action plan in order to insure that your firm will prevent these occurrences in the future.

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 provide specifics of your corrective action plan in order to insure that your firm will prevent these occurrences in the future.

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) Retort System:

(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) Retort System:

(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

Close Out Letter