Baxter Healthcare CorporationAugust 18, 2023

FDA 483 - Baxter Healthcare Corporation - August 18, 2023

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Record Details

An FDA inspection of Baxter Healthcare Corporation in Round Lake, IL, identified that procedures for design validation were not adequately established. Specifically, a claim regarding the Novum IQ Syringe Pump's Smart Battery Pack degradation was not validated using production-equivalent units. This indicates a deficiency in ensuring product claims are thoroughly tested according to established procedures.

Company: Baxter Healthcare Corporation
Inspection Date: August 18, 2023
Product Type: Device
Office: Chicago District Office
People: Kyran R Gibson
Nicholas Z. Lu

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ID · 448b5015-bafe-4bcc-990e-1b4b6fb19bdf