A September 2026 FDA Warning Letter to Baxter International identifies deficiencies in cross-contamination prevention, aseptic processing, environmental monitoring and quality investigations. The findings highlight why a documented Contamination Control Strategy (CCS) must be supported by evidence that manufacturing processes remain under control. The US Food and Drug Administration (FDA) issued a Warning Letter to Baxter International on 29 September 2026 following an inspection of Baxter Healthcare Corporation’s manufacturing facility in Round Lake, Illinois, from 23 March to 2 April 2026. The FDA identified significant violations of current good manufacturing practice...