FDA 483 - Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd. - March 07, 2025

An FDA inspection of Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd. in Hangzhou, China, revealed significant deficiencies in equipment cleaning, out-of-specification investigation procedures, and quality control unit adherence to GMP documentation. Inspectors found active pharmaceutical ingredient residue in "cleaned" equipment, inadequate OOS investigations, and discarded GMP documents in the QC lab. These observations indicate a lack of control over manufacturing processes and quality systems.