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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.

Eaglelionton Int'l Trading Co Inc, Brooklyn, NY, FSVP Violations

FDA issued a warning letter to Eaglelionton Int'l Trading Co Inc, a Brooklyn-based food importer, citing significant violations of the Foreign Supplier Verification Program (FSVP) regulation under 21 CFR part 1, subpart L and section 805 of the FD&C Act. The firm failed to develop an FSVP for any imported foods, including coconut milk, canned products, and other items sourced from foreign suppliers in unspecified countries. FDA has placed the firm on notice that foods from identified foreign suppliers may be subject to detention without physical examination (DWPE) under Import Alert #99-41, and future imports may be refused admission.