FDA 483 - Xinxiang Tuoxin Pharmaceutical Co. Ltd - June 06, 2019

An FDA inspection of Xinxiang Tuoxin Pharmaceutical Co., Ltd in Xinxiang, China, revealed significant deficiencies across multiple areas of their operations. The firm failed to adequately establish impurity profiles, validate analytical methods, ensure data integrity in computerized systems, and properly handle product quality complaints. These observations indicate a need for improved quality control and adherence to good manufacturing practices.