FDA EIR - Chaohu Daxin Foodstuffs Co., Ltd. - July 23, 2024

An FDA inspection of Chaohu Daxin Foodstuffs Co., Ltd., a Chinese seafood manufacturer, was conducted from July 22-23, 2024. The inspection focused on the company's production of frozen cooked crawfish tail meat for export to the U.S., under the regulatory framework of FDA's Seafood HACCP and Preventive Controls programs, consistent with the Federal Food, Drug, and Cosmetic Act. The inspection revealed significant issues, leading to the issuance of a Form FDA-483. Main violations included the failure to adequately implement monitoring and verification procedures specified in the firm's HACCP Plan. This was evident in inconsistent record-keeping for steam temperature and conveyor belt speed, and a lack of verification for raw material supply certificates and finished product pesticide samples. Furthermore, the company was found not to be monitoring conditions and practices with sufficient frequency to ensure Current Good Manufacturing Practices. Specific concerns included the safety of water in contact with food, cleanliness of food contact surfaces, prevention of cross-contamination (e.g., unwashed hands, inadequate sanitation practices), and protection against food adulteration, including condensation buildup and the absence of environmental monitoring for Listeria. Additionally, the company's president declined to provide shipping records for a specific crawfish batch, citing trade secrets. Management acknowledged the findings and committed to implementing voluntary corrections and providing a written response to the FDA within 15 business days. A verbal recommendation was also made for senior management to undergo specific seafood HACCP training. The FDA advised the firm of potential enforcement actions, including Warning Letters and Import Alerts, for non-compliance.