FDA WARNING_LETTER - Shah Poran Distributors Inc

On June 24, 2015, the FDA inspected Shah Poran Distributors Inc.'s seafood importer establishment in Maspeth, NY. 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 primary violation identified was the firm's failure to implement an affirmative step to ensure that imported frozen Shad, Hilsa (Tenualosa ilisha) fish, manufactured and distributed by specific entities in (b)(4), were processed in accordance with the seafood HACCP Regulation, as required by 21 CFR 123.12(a)(2)(ii). This deficiency renders the imported fish 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 potentially injurious to health.

The FDA warned that failure to promptly correct these violations could lead to further actions, 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