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Trang Thuy Seafood Co., LTD, a Vietnamese seafood processor, was cited for serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations in its production of frozen, vacuum-packed yellowfin tuna loins. The FDA conducted a foreign remote assessment following a consumer complaint of histamine poisoning that triggered a voluntary recall, and determined the company's products were adulterated due to failures to implement a compliant HACCP plan and operate according to 21 CFR Part 123 requirements. Despite the company's August 2023 submission of corrective actions including an updated HACCP plan and sanitation procedures, the FDA's evaluation revealed the serious HACCP compliance concerns persisted.