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Talk to a SpecialistTalk to a SpecialistMarumo Co., Ltd., a Japanese seafood processor, received a warning for serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations governing their dried shaved skipjack tuna products. During an FDA inspection in January 2023, investigators identified failures to develop and implement compliant HACCP plans as required under 21 CFR 123, rendering the products adulterated under the Federal Food, Drug, and Cosmetic Act. The company's February 2023 response, which included an experimental report and corrective action descriptions, was deemed inadequate by the FDA. The violations created potential health risks as the products were prepared and held under conditions that may have rendered them injurious to health.