FDA 483 - Baxter Healthcare Corporation - September 28, 2016

An FDA inspection of Baxter Healthcare Corporation in Deerfield, IL, revealed significant deficiencies in their pharmacovigilance system. The firm failed to promptly review adverse drug experience information, leading to incorrect identification and reporting of numerous serious and unexpected adverse events. This non-compliance stemmed from issues within specific programs and a broader culture of non-compliance, including inadequate training and adherence to internal policies.