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Chaohu Daxin Foodstuffs Co., Ltd., a Chinese seafood manufacturer, failed to establish and implement a compliant Hazard Analysis and Critical Control Point (HACCP) plan for its ready-to-eat cooked crawfish products as required under 21 CFR Part 123, rendering the products adulterated. During a July 2024 inspection, FDA investigators identified serious violations of seafood HACCP regulations and Current Good Manufacturing Practice requirements, which the company's August 2024 corrective action response failed to adequately address. The facility's failure to establish critical limits in its HACCP plan—a foundational requirement under 21 CFR 123.6(c)(3)—meant the products were prepared and held under conditions whereby they may have been rendered injurious to health.