FDA 483 - Baxter Pharmaceuticals India Pvt Ltd - May 17, 2022

An FDA inspection of Baxter Pharmaceuticals India Pvt Ltd in Ahmedabad, India, from May 9-17, 2022, revealed severe and recurring deficiencies in its sterile manufacturing operations. The firm demonstrated inadequate quality unit oversight, insufficient investigations into cGMP discrepancies and OOS results, and failures in environmental monitoring and aseptic practices. Many of the issues cited were previously identified in past FDA inspections, including a 2018 Warning Letter, indicating a systemic failure to implement effective corrective actions.