FDA 483 - Sun Pharmaceuticals Industries Ltd. - March 29, 2019

An FDA inspection of Sun Pharmaceutical Industries Limited in Dadra, India, revealed significant deficiencies across its quality, production, and facilities systems. The firm was cited for inadequate employee training, lack of proper production and process controls, insufficient investigation of errors, and poor equipment cleaning. These issues indicate a systemic failure to ensure drug product quality and compliance with Good Manufacturing Practices.