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Talk to a SpecialistTalk to a SpecialistReunipeche SAS, a seafood processing facility in Réunion, France, was cited for serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations under 21 CFR Part 123 during an FDA inspection in July 2024. The company's whole fresh fish products were deemed adulterated because the facility failed to develop and implement a compliant HACCP plan, despite submitting responses that included risk analysis documents, temperature monitoring procedures, and supporting records. The FDA determined that the submitted documentation and corrective actions remained inadequate to address the fundamental HACCP program deficiencies, rendering the seafood products potentially injurious to health under the Federal Food, Drug and Cosmetic Act.