FDA WARNING_LETTER - Packers Provisions Co. of PR - May 30, 2008

An FDA inspection of Packers Provisions Co. of PR, a seafood importer, conducted on May 29-30, 2008, revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, specifically 21 CFR Part 123 and 21 CFR 123.12, concerning special requirements for imported products. The primary deficiency identified was the firm's failure to implement an affirmative step to ensure that imported fish and fishery products are processed in accordance with seafood HACCP regulations, as required by 21 CFR 123.12(a)(2). This was observed for various products including paella seafood, seafood mix, kingfish, dried salted pollock fillets, and crabmeat. Due to these recurrent serious violations, products such as paella seafood, seafood mix, pollock fillets, kingfish, octopus, and imitation crab meat are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. The FDA warned that further action might include refusal of admission under Section 801(a) of the Act, detention without physical examination, product seizure, or injunction. The firm is required to respond in writing within fifteen working days, detailing specific corrective actions, including HACCP and importer verification records, and documentation of affirmative steps taken to ensure compliance. Failure to correct these violations could lead to severe business and operational consequences.