U.S. FDA· FDA·· 4 hours agoPickScore57
Baxter International Inc. - 733231 - 09/29/2026
In brief
On September 29, 2026, the FDA issued a warning letter (reference 320-26-132) to Baxter International citing serious CGMP violations at its sterile injectable manufacturing facility in Round Lake, Illinois (FEI 1416980). The violations were found during an inspection conducted from March 23 to April 2, 2026.
Why it matters
It details cross-contamination, sterilization validation and deviation investigation deficiencies at a sterile injectables facility, useful as a CGMP remediation reference.
Source: U.S. FDA