FDA WARNING_LETTER - Kencor Ethnic Foods, Inc - October 20, 2011

On December 13, 2011, the FDA issued a Warning Letter to Kencor Ethnic Foods, Inc. following an inspection of their seafood processing facility in Kenosha, Wisconsin, on October 5, 14, and 20, 2011. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and the Current Good Manufacturing Practice (CGMP) regulation for foods (21 CFR Part 110).

The FDA determined that Kencor Ethnic Foods' dried Pike, Tilapia, Cod, Catfish, Carp, and Herring products were adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under insanitary conditions.

Key violations included: * **Lack of HACCP Plan:** The firm did not have a HACCP plan for Dried Herring to control pathogen growth and toxin formation, including Scombrotoxin (21 CFR 123.6(a) and (b)). * **Incomplete Hazard Analysis:** The HACCP plan for Dried Pike, Tilapia, Cod, Flathead Catfish, and Big Head Carp failed to list metal as a food safety hazard, despite the use of equipment that could introduce metal into the products (21 CFR 123.