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

The FDA issued a warning letter to the seafood manufacturing facility in Zhegao Town, Chaohu, Anhui, China, operated by Mr. Gan Shidong, following an inspection conducted on July 22-23, 2024. The inspection revealed significant violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice (CGMP) requirements (21 CFR Part 117).

Key violations included inadequate HACCP plans for controlling food safety hazards in their ready-to-eat cooked crawfish products. Specifically, the critical limits for controlling pathogenic bacteria were insufficient, and monitoring procedures lacked continuous oversight of cooking temperatures and belt speeds. Additionally, the facility failed to address chemical contaminants like pesticides and did not consistently review supply certificates for crawfish batches.

Sanitation practices were also found lacking, with observations of cracked and stained conveyor belts and condensate dripping onto food contact surfaces. The facility"s response to the initial FDA Form 483 was deemed inadequate, as it did not provide sufficient evidence of corrective actions or compliance with U.S. standards.

The FDA requires the company to submit a written response within 15 working days, detailing corrective measures, including updated HACCP plans, monitoring records, and any additional documentation to demonstrate compliance. Failure to address these issues could result in further regulatory actions.