Baxter Healthcare CorporationNovember 25, 2025

FDA 483 - Baxter Healthcare Corporation - November 25, 2025

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Record Details

The FDA inspected Baxter Healthcare Corporation in Round Lake, IL, a contract laboratory, and issued a Form 483 with five observations. The inspection revealed significant deficiencies in laboratory controls, quality control unit oversight, computer system controls, personnel training, and laboratory record-keeping. These issues primarily concern environmental monitoring, cross-contamination risks, and data integrity for drug products.

Company: Baxter Healthcare Corporation
Inspection Date: November 25, 2025
Product Type: Drugs
Office: FDA District Office — Chicago, Illinois
Person: Shafiq S. Ahadi (Investigator)

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