FDA warns Baxter International over CGMP violations at Illinois sterile injectables plant
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On September 29, 2026, the FDA issued warning letter 320-26-132 to Baxter International, citing serious current good manufacturing practice (CGMP) violations at the company's sterile injectable manufacturing facility in Round Lake, Illinois (FEI 1416980). The violations were identified during an FDA inspection of the site conducted from March 23 to April 2, 2026. The facility produces sterile injectable medicines, a product class where manufacturing lapses carry direct risks to patient safety. The warning letter places the site under heightened regulatory scrutiny, and Baxter's response, any corrective actions, and potential follow-up measures from the FDA have not yet been reported.
Written by a model from the reports · updated 4 hours ago
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- U.S. FDAPickBaxter International Inc. - 733231 - 09/29/2026
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.
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