FDA WARNING_LETTER - Fatima Brothers - February 23, 2015

On February 23, 2015, the FDA inspected Fatima Brother, a seafood importer located at 5605 55th Drive, Maspeth, 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 fish and fishery products, specifically canned mackerel in tomato sauce and canned sardines in tomato sauce manufactured by (b)(4) in (b)(4), were processed in accordance with the seafood HACCP Regulation, as required by 21 CFR 123.12(a)(2)(ii). This renders the shelf-stable canned ready-to-eat (RTE) Mackerel in concentrated tomato sauce 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 preparation, packing, or holding under insanitary conditions.

The FDA warns that failure to promptly correct these violations may result in refusal of admission of imported products under Section 801(a) of the Act, including "detention without physical examination," product seizure, and/