FDA WARNING_LETTER - Inter-Ocean Seafood Traders Inc - November 17, 2010

On January 5, 2011, the FDA issued a Warning Letter to Inter-Ocean Seafood Traders, Inc. following an inspection from November 15-17, 2010. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123, specifically concerning imported fish and fishery products under 21 CFR 123.12.

The firm's frozen shrimp and prawns were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4), due to being prepared, packed, or held under insanitary conditions.

Key violations included: 1. Failure to have product specifications designed to ensure imported fish and fishery products are not injurious to health, specifically lacking specifications to address undeclared sulfites in shrimp imported from Ecuador, Nicaragua, and Indonesia, violating 21 CFR 123.12(a)(2)(i). 2. Failure to implement an affirmative step to ensure imported frozen shrimp from foreign suppliers were processed in accordance with FDA's seafood HACCP regulations, specifically to address the hazard of undeclared sulfites, violating 21 CFR 123.12(a)(2)(ii).

The FDA warned