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Jolca, S.A., a seafood processing facility in Spain, was warned for serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations under 21 CFR 123 during a Foreign Regulatory Assessment conducted in October 2023. The company's ready-to-eat cold smoked salmon products were found to be adulterated because the facility failed to have and implement a compliant HACCP plan and did not conduct proper hazard analysis as required. These violations rendered the seafood products potentially injurious to health and in violation of the Federal Food, Drug and Cosmetic Act.