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Talk to a SpecialistTalk to a SpecialistMariscos Procesados - CAMPRESA - S.A., a seafood processing facility in Nicaragua, was cited for serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations under 21 CFR Part 123 during an FDA inspection conducted August 12-16, 2024. The company failed to conduct adequate hazard analysis and establish compliant HACCP plans for frozen whole fish and fillet products, particularly regarding histamine control, rendering their frozen mahi-mahi fillets adulterated under the Federal Food, Drug, and Cosmetic Act. The company's corrective action responses submitted in August and September 2024 were deemed inadequate by FDA evaluators to address the underlying compliance failures.