FDA WARNING_LETTER - Adamba Imports International Inc. - April 16, 2015

On April 16, 2015, the FDA inspected Adamba Imports International Inc. at 585 Meserole Street, Brooklyn, NY 11237, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123, specifically 21 CFR 123.12 for imported fish and fishery products.

The firm failed to implement an affirmative step to ensure that imported refrigerated ready-to-eat (RTE) Herring Fillets in plastic containers and shelf-stable RTE Mackerel Fillets Catalina Style in metal cans, manufactured by (b)(4) in (b)(4), were processed in accordance with the seafood HACCP Regulation, violating 21 CFR 123.12(a)(2)(ii). This renders the products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 342(a)(4)), as they were prepared, packed, or held under insanitary conditions.

Failure to correct these violations may result in refusal of admission for imported products under Section 801(a) of the Act, including "detention without physical examination," product seizure, and/or injunction. The firm must respond in writing within fifteen working days, outlining specific corrective actions, including documentation of