FDA 483 - Zhejiang Medicine Co. Ltd. Xinchang Pharmaceutical Factory - March 07, 2025

Zhejiang Medicine Co. Ltd. Xinchang Pharmaceutical Factory, a human drug and API manufacturer in Xinchang, P.R. China, was inspected by the FDA. The inspection revealed that the firm's written stability program for drug substances is not stability indicating. This deficiency raises concerns about the assurance of analytical methods used to test drug substances for purity and the quality of products shipped to the U.S. market.