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Comercializadora Internacional Piscicola New Your S.A, a Colombian seafood processor, failed to establish and implement a compliant Hazard Analysis and Critical Control Point (HACCP) plan as required under 21 CFR 123, rendering their fresh and frozen fish products adulterated. During a Foreign Remote Regulatory Assessment in May 2023, FDA investigators identified that the company did not conduct proper hazard analyses for each type of fish and fishery product produced, a critical violation of seafood HACCP regulations. The firm's failure to respond to the inspection observations and lack of corrective action prompted the January 2024 warning letter, which classified their seafood products as potentially injurious to health due to improper preparation, packing, and handling conditions.