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Independent Seafoods Panama, S.A. failed to comply with seafood Hazard Analysis and Critical Control Point (HACCP) regulations under 21 CFR Part 123 during an FDA inspection conducted June 12-13, 2023, rendering their fresh artisanal fish and histamine fish products adulterated. The company did not conduct proper hazard analysis for each type of fish and fishery product produced to identify food safety hazards reasonably likely to occur, nor did they implement compliant HACCP plans as required. These serious violations meant the seafood products were prepared, packed, or held under conditions whereby they may have been rendered injurious to health.