FDA WARNING_LETTER - Porky Products Inc. - May 17, 2011

On April 28, 2011, the FDA inspected Porky Products Inc. in Carteret, NJ, and found serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 123). The firm's imported fish and fishery products, including Salted Smoked Split Herring, Vacuum Packed Back-Split Salted Mackerel, Salt Mackerel Fillets in Brine, and Pickled Back-Split Mackerel, were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act).

Key violations include: 1. Failure to have a HACCP plan for Vacuum Packed Back-Split Salted Mackerel to control histamine and pathogen growth (21 CFR 123.6(a) and 123.6(b)). 2. HACCP plan for Smoked/Salted Mackerel products (Salt Mackerel Fillets in Brine and Pickled Back-Split Mackerel) did not list histamine and pathogen growth as food safety hazards (21 CFR 123.6(a) and 123.6(c)(1)). 3. Inadequate critical limit of "must receive product at 40 degrees or less" at the Receiving critical control point for Smoked/Salted products, insufficient to control histamine and pathogen growth, especially given