FDA 483 - Zhejiang Dingtai Pharmaceutical Co., Ltd - January 25, 2019

An FDA inspection of Zhejiang Dingtai Pharmaceutical Co., Ltd. in Tongxiang, China, revealed significant deficiencies across four observations. The firm failed to maintain adequate laboratory controls, including system suitability testing and electronic data review, and exhibited poor data integrity practices. Additionally, batch production and control records were incomplete, lacking documentation of critical manufacturing steps and proper record reconciliation, indicating a general lack of adherence to good manufacturing practices.