FDA 483 - Taizhou Xianju Pharmaceutical Co. Ltd. - March 27, 2017

Taizhou Xianju Pharmaceutical Co. Ltd. in Taizhou, China, an active pharmaceutical manufacturer, was cited with three observations during an FDA inspection. The inspection revealed significant issues including failures in quality unit procedures for product labeling leading to mislabeling, inadequate controls for objectionable contamination, and deficiencies in warehousing procedures for temperature and humidity monitoring. These findings indicate a lack of adherence to good manufacturing practices.