FDA WARNING_LETTER - Pacific American Fish Co. Inc. - March 11, 2008

On March 11, 2008, the FDA inspected Pacific American Fish Co Inc. in Vernon, CA, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123, specifically 21 CFR 123.12. As an importer, the firm failed to implement an affirmative step to ensure that imported fish and fishery products are processed in accordance with the seafood HACCP regulation, as required by 21 CFR 123.12(a)(2)(ii). This deficiency was noted for Frozen Mackerel, Frozen Amberjack Loin, and Chilled Mahi Mahi. Consequently, these products are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. The FDA mandates that importers provide evidence that all imported fish and fishery products comply with 21 CFR Part 123. Failure to do so can result in refusal of admission, detention without physical examination, product seizure, or injunction. The firm must respond in writing within fifteen working days, detailing corrective actions, including HACCP and importer verification records, and documentation of affirmative steps taken.