FDA 483 - Baxter Healthcare Corporation - March 29, 2010

Baxter Healthcare Corp. in Deerfield, IL, was inspected and cited for multiple deficiencies related to its quality system for medical devices. The observations primarily concern inadequate management reviews, incomplete CAPA procedures, failure to implement corrective actions, insufficient analysis of quality data, and issues with supplier controls and quality audits. These issues indicate a systemic breakdown in ensuring product quality and compliance with regulatory requirements.