FDA 483 - Baxter Healthcare Corporation - October 31, 2023

Baxter Healthcare Corporation in Marion, NC, a human drug manufacturer, was inspected by the FDA from October 23-31, 2023. The inspection revealed significant deficiencies across production and process controls, equipment design and maintenance, and laboratory controls. These issues included the presence of microscopic fibers in drug products, inadequate visual inspection procedures for particulates, poorly designed and maintained manufacturing equipment, and insufficient environmental monitoring and bioburden testing protocols.