FDA 483 - Baxter Pharmaceuticals India Pvt Ltd - June 27, 2025

Baxter Pharmaceuticals India Pvt Ltd. in Ahmedabad, India, a sterile drug product manufacturer, received a Form 483 with three observations. The inspection revealed significant deficiencies including a lack of written procedures for production and process controls, inadequate investigations into Out-of-Specification results and recurring issues like pH instability and particle contamination, and a failure to timely submit Field Alert Reports. These findings indicate systemic quality control and reporting failures.