FDA 483 - Aragen Life Sciences Limited - January 23, 2026

This FDA Form 483 was issued to Aragen Life Sciences Limited in Hyderabad, India, an active pharmaceutical ingredient manufacturer, following an inspection from January 19-23, 2026. The inspection revealed significant deficiencies in equipment cleaning and maintenance, inadequate written procedures for production and process controls, and a failure to thoroughly investigate batch discrepancies and out-of-specification results. These findings indicate a lack of control over critical manufacturing processes that could impact drug substance quality.