FDA 483 - Senador Laboratories Private Limited - November 24, 2025

An FDA inspection of Senador Laboratories Private Ltd. in Ahmedabad, India, a sterile drug manufacturer, revealed significant deficiencies across its quality system. Observations included a lack of scientifically justifiable in-process controls for visual inspection, inadequate investigations into batch failures, and multiple issues with quality control unit procedures. These issues encompass insufficient visual inspection training, unsupported sampling plans, missing qualified test methods, and poor environmental monitoring data management.