FDA WARNING_LETTER - ZHOUSHAN HAICHANG FOOD CO.,LTD. - March 04, 2022

An FDA inspection of Zhoushan Haichang Co. Ltd. in China on March 3-4, 2022, revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their frozen (cut) swimming crab products adulterated. Key deficiencies include the firm's HACCP plan for frozen (cut) swimming crab failing to list labeling as a critical control point for sulfites, which requires declaration at 10 ppm or greater. Additionally, the HACCP plan did not identify allergens (crustacean) as a reasonably likely food safety hazard. The firm also failed to monitor processing conditions and practices with sufficient frequency to ensure conformance with Current Good Manufacturing Practice requirements (21 CFR 117, Subpart B), specifically regarding the safety of water used to produce ice, which was observed to contain debris and residue. The FDA requires a written response within fifteen working days outlining specific corrective actions, including revised HACCP plans and five consecutive days of monitoring records. Failure to adequately respond may result in refusal of admission of imported products into the U.S., including detention without physical examination (DWPE) under Import Alert #16-120.