FDA 483 - Zhejiang Xianju Pharmaceutical Co., Ltd. (Yangfu API). - August 23, 2019

An FDA inspection of Zhejiang Xianju Pharmaceutical Co., Ltd in Xianju, China, revealed one observation concerning the lack of audit trail review for critical analytical instruments. These instruments are used for release testing of APIs destined for the U.S. market, indicating a potential issue with data integrity and quality control practices.