FDA WARNING_LETTER - Xiamen Kang Zhongyuan Biotechnology Co., Ltd. - August 15, 2025

Xiamen Kang Zhongyuan Biotechnology Co., Ltd. received an FDA warning letter following an inspection conducted from August 12 to 15, 2025. The agency identified significant violations of the Federal Food, Drug, and Cosmetic Act, determining that drug products were manufactured under insanitary conditions and that the firm failed to maintain accurate records. During the inspection, investigators observed numerous facility deficiencies, including mold on air vents, standing water in production areas, grime on machinery, and the presence of pests such as flies and cockroaches. Additionally, the FDA uncovered serious data integrity lapses, where the company"s leadership admitted to falsifying testing documents and altering manufacturing logs during the inspection.

Under the regulatory framework of the FD&C Act, these violations render the company"s products adulterated and potentially injurious to health. As a result, the FDA has placed the firm on Import Alert 66-40, effectively blocking their products from entering the United States. Following a teleconference with the agency, the company also agreed to initiate a recall of certain lots of mentholated cough drops.

To address these violations, the FDA requires the company to hire an independent consultant to investigate the full scope of their data inaccuracies and conduct a comprehensive risk assessment. The firm must also submit a detailed corrective action plan that includes improved facility maintenance, strict pest control protocols, and enhanced management oversight to ensure manufacturing reliability. A formal response detailing these remediation efforts is required within 15 working days.