FDA 483 - Baxter Healthcare Corporation - June 09, 2022
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An FDA inspection of Baxter Healthcare Corporation revealed that procedures for corrective and preventive action (CAPA) were not adequately established. The firm failed to initiate necessary software updates for marketed Voalte Nurse Call software to address a design requirement non-adherence, despite an informal plan and a related nonconformance evaluation. This indicates a significant lapse in their quality system regarding product corrections and preventive measures.
ID · 241a2569-fb3a-4bff-89f7-82b925b3456f