Hainan Golden Spring Foods Co. Ltd. – FDA Warning Letter, Dec 15, 2021

On May 4, 2022, the FDA issued a Warning Letter to Hainan Golden Spring Foods Co. Ltd. following an inspection from December 13-15, 2021. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123), rendering their raw frozen reduced oxygen packed tilapia fillets and whole tilapia G&S products adulterated.

The primary violation was the firm's failure to implement required monitoring and verification procedures for aquaculture drug residues at the critical control point (CCP1) in their HACCP plan for raw frozen reduced oxygen packed tilapia fillets. Specifically, production records showed more drug residue tests than were actually conducted according to laboratory equipment logs for finished product lots #(b)(4) and #(b)(4). The firm could not explain the discrepancy due to a lack of sample preparation records, and laboratory employees estimated only (b)(4)% of reported tests were performed.

The company's January 5, 2022, response, including a revised HACCP plan and monitoring records, was deemed inadequate. The submitted inter-laboratory comparison report was not representative, comparing only a single test from a single lot, and failed to demonstrate the firm's test kits could detect aquaculture drugs at the reported level compared to national standards.

Hainan Golden Spring Foods Co. Ltd. must respond within fifteen working days, outlining specific corrective actions, including