FDA 483 - Xiamen Tiger Medical Co., Ltd. - December 19, 2023

Xiamen Tiger Medical Co., Ltd. was inspected by the FDA from December 14-19, 2023, revealing significant deficiencies in quality control, production processes, and data integrity. Observations included inadequate sampling and testing plans, failure to establish proper production controls, insufficient investigation of discrepancies and batch failures, and lack of secure data backup. These issues indicate a serious lack of adherence to good manufacturing practices.