Seven Seas Seafoods Inc. – FDA Warning Letter, Sep 6, 2011

The FDA inspected Seven Seas Seafoods Inc. from September 1st to September 6th, 2011, revealing significant violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The firm failed to implement an affirmative step to ensure frozen tuna from (b)(4) was processed according to seafood HACCP regulations (21 CFR 123.12(a)(2)(ii)). Additionally, the firm lacked product specifications to ensure the imported frozen tuna from (b)(4) was not injurious to health (21 CFR 123.12(a)(2)(i)).

As an importer, Seven Seas Seafoods Inc. must comply with 21 CFR 123.12, requiring evidence that all imported fish and fishery products meet 21 CFR Part 123 standards. The imported frozen tuna products are considered adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 342(a)(4)) due to insanitary conditions.

Future entries of these seafood products may be detained under section 801(a) of the Act (21 U.S.C. § 381(a)) and listed on Import Alert 16-119, leading to detention without physical examination