FDA 483 - Sun Pharmaceutical Industries Ltd. - May 09, 2022

Sun Pharmaceutical Industries Ltd. in Halol, Gujarat, India, received a Form 483 with 10 observations primarily concerning aseptic processing, environmental monitoring, equipment design and cleaning, laboratory controls, quality unit responsibilities, and personnel training. The observations highlight significant deficiencies in preventing microbiological contamination, ensuring product purity, and adequately investigating discrepancies and complaints. The firm also failed to conduct timely stability testing and ensure proper visual inspection of drug products.