FDA 483 - ONESOURCE SPECIALTY PHARMA LIMITED - March 28, 2025

ONESOURCE SPECIALTY PHARMA LIMITED, a sterile drug manufacturer in Bengaluru, India, was cited for significant deficiencies in its aseptic processing and quality control systems. The inspection revealed inadequate validation of aseptic processes, including media fills and air flow studies, and a failure to establish robust process control procedures with statistical sampling. Additionally, the firm's intervention procedures for vial filling were incomplete, and its environmental monitoring program did not adequately account for dynamic manufacturing conditions.