FDA 483 - Sun Pharmaceutical Medicare Limited - February 05, 2019

An FDA inspection of Sun Pharmaceutical Medicare Limited in Halol, Gujarat, a pharmaceutical manufacturer, revealed a significant issue regarding the firm's failure to thoroughly review unexplained discrepancies and out-of-specification (OOS) results. The firm repeatedly invalidated OOS re-dispersibility test results by attributing them to human error during sample preparation without adequate supporting evidence. This indicates a serious lapse in quality control and investigation procedures.