FDA WARNING_LETTER - Four Star Import & Distribution - December 02, 2011

On December 20, 2011, the FDA issued a Warning Letter to Four Star Import & Distribution, Inc. following an inspection on November 30 and December 2, 2011, at their Brooklyn, NY seafood importer establishment. The inspection revealed a serious violation 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 was the firm's failure to implement an affirmative step to ensure that imported Munia Churi Dry Fish and Noya Boyal Dry Fish from Bangladesh were processed in accordance with seafood HACCP regulations, as required by 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.

The firm's December 2, 2011, response to the FDA 483 was deemed inadequate because it was merely a promise to correct the violation without a timeframe or supporting documentation. The FDA stated that further action, including refusal of admission, detention without physical examination, seizure, and/or injunction