FDA 483 - Baxter Healthcare Corporation - April 04, 2025

An FDA inspection of Baxter Healthcare Corporation in Medina, NY, a medical device manufacturer, revealed two significant observations. The firm's procedures for corrective and preventive actions were found to be inadequately established, particularly concerning investigations and corrective actions for product recalls. Additionally, the company's complaint handling system was cited for insufficient investigations and untimely processing and reporting of medical device reports.