FDA warning letter to Nestle Purina PetCare

http://www.fda.gov/iceci/enforcementactions/warningletters/ucm428841.htm
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.
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