FDA WARNING_LETTER - Evelyn Effan - October 08, 2015

On October 8, 2015, the FDA inspected Ms. Evelyn Effan's seafood importer establishment at 1151 East 229th Street, Apt#5F, 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, which governs imported fish and fishery products.

The primary violation was the firm's failure to implement an affirmative step to ensure imported smoked fish herring and smoked akwabi, manufactured by (b)(4) in (b)(4), were processed in accordance with seafood HACCP regulations, as required by 21 CFR 123.12(a)(2)(ii). These products, under entry number (b)(4), were found to be adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4), because they were prepared, packed, or held under insanitary conditions. Furthermore, FDA laboratory analysis confirmed both the smoked fish herring and smoked akwabi were uneviscerated, rendering them adulterated under Section 402(a)(1) of the Act (21 U.S.C. § 342