FDA 483 - ONESOURCE SPECIALTY PHARMA LIMITED - July 19, 2022

Stelis Biopharma Limited, a drug manufacturer in Bengaluru, India, was cited for five observations during an FDA inspection. Key issues include inadequate equipment design and control, insufficient computer system controls, deficiencies in container closure system protection, failures in quality control unit procedures and documentation practices, and incomplete laboratory records regarding sample receipt dates. The observations indicate significant concerns with manufacturing and quality control processes.