blue pacific seafood, inc. ( – FDA Warning Letter, Mar 5, 2008

On March 5, 2008, the FDA inspected Blue Pacific Seafood, Inc. DBA Shrimp Works, aka Water Works, a seafood importer establishment. The inspection revealed a serious violation of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123, specifically 21 CFR 123.12, which governs imported fish and fishery products.

The primary violation identified was the firm's failure to implement an affirmative step to ensure that imported fresh yellowtail, manufactured by [redacted] in Mexico, was processed in accordance with the seafood HACCP regulation, as required by 21 CFR 123.12(a)(2)(ii). This deficiency renders the fresh yellowtail adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4), indicating it was prepared, packed, or held under insanitary conditions.

The FDA warned that failure to promptly correct these violations could lead to further action, including refusal of admission for imported products under Section 801(a) of the Act (21 U.S.C. §381(a)), "detention without physical examination," product seizure, and/or injunctions. The firm was required to respond in writing within fifteen working days, outlining