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Bacalao Giraldo, S.L.U., a seafood processing facility in Spain, failed to establish and implement a compliant Hazard Analysis and Critical Control Points (HACCP) plan for its refrigerated and frozen desalted cod products in modified atmosphere packaging, rendering them adulterated under federal law. During a May 2024 inspection, the FDA identified serious violations of 21 CFR 123, including the facility's failure to establish critical limits as required by the seafood HACCP regulation. The company's subsequent responses to FDA observations in June, July, and August 2024 were deemed inadequate to address the fundamental HACCP compliance deficiencies.