FDA WARNING_LETTER - Crystal Bay Seafoods, Inc. - February 17, 2012

On February 16-17, 2012, the FDA inspected Crystal Bay Seafoods, Inc. in Green Bay, Wisconsin, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). These violations render products such as Albacore Tuna, Wahoo, Bluefin Tuna, Escolar, Amberjack, Mahi Mahi, Herring fillets, vacuum-packed imitation Crab meat (surimi), and pasteurized canned Blue Swimming Crab Meat adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act).

The primary violation is the firm's failure to conduct a hazard analysis and implement written HACCP plans for several products. Specifically, there are no HACCP plans for Albacore Tuna, Wahoo, Bluefin Tuna, Escolar, Amberjack, Mahi Mahi, Herring fillets in wine sauce, and creamed Herring fillets to control histamine formation. Additionally, there are no HACCP plans for vacuum-packed imitation Crab meat (surimi) and pasteurized canned Blue Swimming Crab Meat to control Clostridium botulinum growth and toxin formation. The firm's temperature monitoring procedures for product receiving and storage are also insufficient to control these hazards.

Furthermore, the firm is cited for not monitoring sanitation conditions and practices, including warehousing,