FDA 483 - Baxter Healthcare (Guangzhou) Co., Ltd. - December 13, 2024

An FDA inspection of Baxter Healthcare (Guangzhou) Co., Ltd. revealed critical deficiencies in quality control and aseptic manufacturing processes. The firm failed to reject defective components, lacked adequate controls to prevent microbiological contamination of sterile drug products, and exhibited poor data integrity practices. These issues led to the shipment of potentially compromised sterile drugs to the U.S. market.