Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd – FDA 483, Aug 18, 2023

Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd was cited for significant deficiencies during an FDA inspection of its sterile drug manufacturing operations. Observations included inadequate procedures for preventing microbiological contamination during aseptic filling, insufficient validation of the aseptic process, and a deficient quality control unit regarding visual inspection speeds. Additionally, the firm lacked appropriate computer system controls to prevent unauthorized data modification in laboratory systems.