FDA WARNING_LETTER - East Oceanic International Co Ltd - July 24, 2015

On July 24, 2015, the FDA inspected East Oceanic International Co Ltd's seafood importer establishment at 47-57 Bridgewater Street, Brooklyn, NY. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123, specifically 21 CFR 123.12, concerning imported fish and fishery products.

The primary violation identified was the firm's failure to implement an affirmative step to ensure that imported ready-to-eat anchovy fish snacks, packaged in hermetically sealed pouches, were processed in accordance with the seafood HACCP Regulation, as required by 21 CFR 123.12(a)(2)(ii). This renders the product adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4), as they were 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 of 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 must respond in writing within fifteen