FDA WARNING_LETTER - Eddies Place d/b/a Esther Kwakyewa - January 07, 2014

On January 2-7, 2014, the FDA inspected Eddies Place d/b/a Esther Kwakyewa, a seafood importer, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). As an importer, the firm must ensure imported fish and fishery products comply with 21 CFR Part 123, or they are considered adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act).

The significant violation was the firm's failure to implement an affirmative step to ensure imported smoked fish herring, salted fish, and fried fish from (b)(4) were processed in accordance with seafood HACCP regulations, as required by 21 CFR 123.12(a)(2)(ii). FDA laboratory analysis of samples collected on (b)(4) revealed all three products were uneviscerated, and the salted fish tested positive for Salmonella. Consequently, these products were deemed adulterated under Section 402(a)(1) of the Act and refused admission on (b)(4).

The FDA may refuse admission of future imports, place products on "detention without physical examination," seize products, or enjoin the firm from further violations. The firm must respond in writing within fifteen working days, outlining specific corrective actions, including HACCP and importer verification records