FDA 483 - Sun Pharmaceutical Medicare Limited - February 27, 2024

An FDA inspection of Sun Pharmaceutical Medicare Ltd., a sterile drug manufacturer in Halol, Gujarat, India, revealed significant deficiencies in preventing microbiological contamination during the manufacturing of sterile drug products. The inspection also cited failures to thoroughly investigate out-of-specification results and atypical events, as well as the use of unqualified production equipment. These observations indicate serious concerns regarding the firm's quality control and manufacturing practices for sterile products.