483
Baxter Healthcare CorporationBaxter Healthcare Corporation – FDA 483, Aug 18, 2023
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.
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ID · 448b5015-bafe-4bcc-990e-1b4b6fb19bdf
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