FDA WARNING_LETTER - Malata African & Caribbean Market - October 02, 2015

On October 2, 2015, the FDA inspected Malata African & Caribbean Market, a seafood importer, at 185 McClellan Street #8, Bronx, 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 was the firm's failure to implement an affirmative step to ensure imported fish and fishery products are processed in accordance with the seafood HACCP Regulation, as required by 21 CFR 123.12(a)(2)(ii). Specifically, Malata African & Caribbean Market did not perform this affirmative step for smoked herring manufactured by (b)(4).

An FDA sample of this smoked herring, imported under entry number (b)(4), was found to be uneviscerated through laboratory analysis. This renders the smoked herring adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 342(a)(4)), as it was prepared, packed, or held under insanitary conditions that may render it injurious to health. This also violates FDA Compliance Policy Guide (CPG) Section 540.650 regarding uneviscerated fish products.

Failure to promptly