FDA 483 - Yangzhou Liberty Pharmaceuticals Co. Ltd. - September 15, 2023

An FDA inspection of Yangzhou Liberty Pharmaceuticals Co. Ltd. in Yangzhou, China, an API manufacturer, revealed a significant issue with equipment maintenance. Specifically, a worn and fractured gasket in a tank used for API manufacturing was observed, and the firm's procedures did not include visual inspection of such gaskets prior to use, leading to potentially compromised batches shipped to the U.S.