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

Chaohu Daxin Foodstuffs Co., Ltd. underwent a comprehensive FDA inspection from July 22-23, 2024, focusing on their frozen cooked crawfish tail meat operations for U.S. export. The inspection was conducted under FDA programs including the Seafood Processor Inspection Program and Preventive Controls for Human Food Operations, requiring adherence to 21 CFR 123 seafood Hazard Analysis and Critical Control Point (HACCP) regulations. The inspection identified significant issues, resulting in a Form FDA-483, Inspectional Observations. Key violations included the failure to adequately implement and verify monitoring procedures outlined in the firm’s HACCP plan, specifically concerning steam temperatures, conveyor belt speeds during cooking, and verification of raw material supply certificates and finished product pesticide testing. Furthermore, the company was found to be insufficiently monitoring conditions and practices to ensure conformance with Current Good Manufacturing Practices. This included concerns about water safety, cleanliness of food contact surfaces, prevention of cross-contamination, maintenance of handwashing facilities, and protection of food from adulteration, alongside a lack of environmental monitoring for pathogens. Additionally, the company's president declined to provide shipping records for U.S.-bound products, citing trade secrets. During the exit interview, FDA verbally recommended that senior management receive specific seafood HACCP training. Management committed to voluntary corrections for all identified issues and pledged to submit a detailed written response to the FDA within 15 business days. The firm was reminded of potential regulatory consequences for non-compliance.