FDA accuses Baxter leaders of ‘inadequate’ oversight after finding GMP failings

The FDA issued a warning letter to Baxter's Round Lake, Illinois, facility over GMP violations including inadequate facility segregation to prevent cephalosporin contamination of other drugs. The FDA noted similar violations date back to January 2025 and involve other Baxter plants, called management oversight "inadequate," and rejected Baxter's corrective response. The letter covers four core issues including microbiological contamination controls and laboratory quality control.