FDA 483 - Sun Pharmaceutical Industries Ltd. - December 13, 2019

Sun Pharmaceutical Industries Ltd. in Halol, India, a sterile and non-sterile drug manufacturer, was cited for multiple significant deficiencies during an FDA inspection. The observations highlight systemic failures in quality control, data integrity, aseptic processing, and manufacturing controls, indicating a lack of robust procedures and oversight to ensure drug product quality and purity. These issues include inadequate investigations into out-of-specification results, manipulable environmental monitoring data, and deficient visual inspection and environmental monitoring procedures.