FDA 483 - CSPC Ouyi Pharmaceutical Co., Ltd. - September 05, 2024

CSPC Ouyi Pharmaceutical Co., Ltd. in Shijiazhuang, China, was inspected and received a Form 483 with five observations. The inspection revealed significant deficiencies in sterile drug product manufacturing, including inadequate sterilization process validation and environmental monitoring in aseptic areas. Additionally, the firm lacked proper data integrity controls for computerized systems and had issues with laboratory testing procedures and record review.