FDA 483 - Ajanta Pharma Ltd. - June 28, 2019

Ajanta Pharma Ltd. in Aurangabad, Maharashtra, India, was cited for five observations during an FDA inspection from June 24-28, 2019. The inspection revealed significant deficiencies in computer system controls, laboratory controls including microbiological testing and instrument calibration, quality control unit responsibilities, and equipment design for an inspection and sorting machine. These issues indicate a lack of appropriate controls and procedures to ensure drug product quality and purity.