FDA 483 - Baxter Healthcare Corporation - December 21, 2018

Baxter Healthcare Corporation received 12 observations related to significant deficiencies in its quality control unit, laboratory operations, and manufacturing processes. Key issues include inadequate complaint evaluation, failure to thoroughly investigate discrepancies and OOS results, lack of proper stability program implementation, and deficiencies in visual inspection certification and supplier management. The firm also failed to maintain facilities and equipment, ensure complete laboratory records for instrument calibration, and establish accurate and reliable test methods, indicating a systemic breakdown in quality assurance and control.