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Martinez Produce & Seafood Inc., a Chicago-based seafood processor and importer, failed to establish and implement a compliant Hazard Analysis and Critical Control Point (HACCP) plan required under 21 CFR Part 123, resulting in their refrigerated fin fish products (tuna, mackerel, flounder, and salmon) being deemed adulterated under the Federal Food, Drug, and Cosmetic Act. During an inspection conducted January 5-14, 2021, the FDA identified serious violations indicating the seafood was prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth or rendered injurious to health. Although the company submitted a written response on February 17, 2021, the FDA determined their corrective actions and HACCP documentation were inadequate to address the violations.