FDA 483 - CSPC Ouyi Pharmaceutical Co., Ltd. - May 17, 2019

An FDA inspection of CSPC Ouyi Pharmaceutical Co., Ltd. in Shijiazhuang, China, revealed that the firm's examination and testing procedures for drug products and in-process materials were inadequate. Specifically, the visual inspection process for tablets did not properly account for unique defects, and the standard operating procedure for tablet press post-processing lacked sufficient detail for defect detection. These issues indicate a moderate severity concern regarding quality control and product efficacy.