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Talk to a SpecialistTalk to a SpecialistPromar Seafood S. de R.L., a seafood processor in Honduras, failed to establish and implement a compliant Hazard Analysis and Critical Control Point (HACCP) plan for its cooked, dried, shelf-stable sea cucumber products intended for the U.S. market, specifically lacking written controls for pathogenic bacteria growth and toxin hazards as required by 21 CFR 123.6(b). During a remote regulatory assessment conducted in January 2022, the FDA identified these serious violations of seafood HACCP regulations, and the company did not respond to the discussion items raised by the investigator. These compliance failures rendered the sea cucumber products adulterated under the Federal Food, Drug and Cosmetic Act, as they were prepared and held under conditions that may have been injurious to health.