FDA 483 - CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co. Ltd - November 11, 2025

CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co. Ltd, a manufacturer of sterile drug products, was cited for significant deficiencies during an FDA inspection. Observations included inadequate validation of aseptic processes, insufficient cleaning and disinfection protocols, and failures in environmental monitoring. Additionally, the firm was found to have poor documentation practices for production and process control procedures.