FDA 483 - Baxter Healthcare Corporation - April 02, 2026

Baxter Healthcare Corporation's sterile drug manufacturing facility in Round Lake, IL, was cited for significant deficiencies across its quality control and production processes. The inspection revealed failures in thoroughly investigating discrepancies, validating aseptic processes, maintaining adequate visual inspection controls, and ensuring proper equipment design and personnel training. These issues collectively indicate a lack of robust control over manufacturing and laboratory operations, posing risks to product quality and sterility.