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CGMP Violations, Insanitary Conditions, Data Integrity Failures, China

FDA issued Warning Letter 320-26-56 to Xiamen Kang Zhongyuan Biotechnology Co., Ltd., a Chinese drug manufacturer (FEI 3027976266), following an August 2025 inspection that identified CGMP violations including insanitary conditions and data integrity failures. Investigators observed equipment contamination with grime and discolored lubricant, standing water in manufacturing areas, visible dirt on production equipment, flies, cockroaches in packaging areas, and apparent mold on air-conditioning vents. The firm's Chief Quality Officer admitted to providing false documents, and the firm supplied altered manufacturing records during the inspection. All drugs from the firm were placed on Import Alert 66-40 on March 20, 2026, and the firm agreed to recall certain lots of mentholated cough drops.