FDA 483 - Ajanta Pharma Limited - September 09, 2022

During an inspection, Ajanta Pharma Limited in Bharuch, India, a human drug manufacturer, was cited for two significant issues. The firm failed to thoroughly investigate unexplained discrepancies, specifically regarding tablet anomalies and unqualified visual inspection equipment. Additionally, the company lacked appropriate controls over computer systems, with critical software for tablet manufacturing equipment not being validated in accordance with established procedures, including 21 CFR Part 11 compliance.