FDA WARNING_LETTER - D&C Seafood, Inc - July 26, 2021
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On September 15, 2021, the FDA issued a Warning Letter to a seafood processing facility at 391 Venice Boat Harbor Road, Venice, LA 70091, following an inspection on July 26, 2021. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123.
The FDA determined that the firm's king mackerel, wahoo, barracuda, and cobia products are 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 that may render them injurious to health.
Specifically, the firm failed to conduct a hazard analysis and implement written HACCP plans as required by 21 CFR 123.6(a) and (b). Violations include the lack of HACCP plans for: 1. King mackerel and wahoo to control histamine formation. 2. King mackerel and barracuda to control ciguatera toxin. 3. King mackerel, wahoo, barracuda, and cobia to control undeclared allergens.
The firm did not submit a response to these violations. The FDA requires prompt corrective action within fifteen working days of
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