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OOO "Elanders", a seafood processing facility in Latvia, was found to have serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations during an FDA inspection in July 2022, rendering their ready-to-eat products including cold smoked mackerel and salted herring fillets adulterated. The facility failed to properly develop and implement compliant HACCP plans, as evidenced by deficiencies that persisted even after the company submitted revised plans in response to the FDA-483 inspection observations. These violations of 21 CFR Part 123 meant the seafood products were considered adulterated under the Federal Food, Drug, and Cosmetic Act due to being prepared, packed, or held under conditions that may have rendered them injurious to health.