FDA WARNING_LETTER - Bay View Packing Company - October 03, 2012

On November 1, 2012, the FDA issued a Warning Letter to Bay View Packing Co. following an inspection of their Milwaukee, Wisconsin seafood processing facility on September 25, 26, and October 3, 2012. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123).

The FDA determined that the firm's Herring Party Bites in Wine Sauce, Herring Party Bites in Sour Cream, and Rollmop Herring products were adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, having been prepared, packed, or held under insanitary conditions.

Key violations included: 1. Failure to conduct a hazard analysis and implement a written HACCP plan for Herring Party Bites in Wine Sauce, Herring Party Bites in Sour Cream, and Rollmop Herring to control hazards such as histamine development, pathogen growth, and Clostridium botulinum formation, as required by 21 CFR 123.6(a) and (b). 2. Insufficient monitoring procedures in the HACCP plan for these products, specifically lacking controls for: * Temperature monitoring of incoming herring to prevent histamine and Clostridium botulinum. * Frequent temperature monitoring of walk-in coolers storing herring ingredients and finished products to ensure temperatures do not exceed limits.