FDA cites Baxter’s inadequate oversight after repeated GMP violations at multiple plants

The U.S. Food and Drug Administration has issued a warning letter to Baxter International, saying the company's leadership has failed to provide adequate oversight of its drug manufacturing operations.

Inspectors visited Baxter’s Round Lake, Illinois, facility in March and April and identified GMP shortcomings. The agency noted that similar violations were documented at the same plant in January 2025 and at other Baxter sites, indicating a pattern of repeated failures.

The Round Lake plant, one of Baxter’s three main pharmaceutical manufacturing locations, produces antibiotics such as cefazolin, vancomycin and the combination product Zosyn. The FDA highlighted that inadequate controls could allow antibiotic residues to contaminate other drug products, posing safety risks.

The FDA concluded that the repeated problems across multiple sites reflect insufficient management control and called for immediate improvements in oversight and manufacturing practices.