483
Baxter Healthcare CorporationBaxter Healthcare Corporation – FDA 483, Nov 25, 2025
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.
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ID · 195c262e-ca8e-4c23-8651-c58f69d9025c
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