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

An FDA inspection of Chaohu Daxin Foodstuffs Co., Ltd. in Chaohu, Anhui, China, was conducted from July 22-23, 2024. The inspection, governed by the Seafood HACCP regulation (21 CFR 123) and Preventive Controls for Human Food, focused on the company's manufacturing of frozen cooked crawfish tail meat destined for the United States. Key violations noted in the Form FDA-483, Inspectional Observations, included the firm's failure to adequately implement monitoring and verification procedures stipulated in its Hazard Analysis and Critical Control Point (HACCP) Plan. Specifically, issues arose with consistent monitoring and verification of critical control points such as steam temperature and conveyor belt speed, as well as the frequency of monitoring raw material supply certificates and pesticide sampling.

Additionally, the inspection identified insufficient monitoring of conditions and practices essential for Current Good Manufacturing Practices (cGMP). This included concerns about the safety of water used in food contact, the cleanliness of food contact surfaces, prevention of cross-contamination, proper maintenance of handwashing and toilet facilities, and protection of food from adulteration, such as condensate accumulation and a lack of environmental monitoring for Listeria. Management committed to voluntary corrections and will submit a written response to the FDA within 15 business days. A verbal recommendation for senior management to complete specific seafood HACCP training was also made, and the company was reminded of potential FDA enforcement actions for non-compliance.