FDA 483 - Solara Active Pharma Sciences Limited - March 07, 2020

An FDA inspection of Solara Active Pharma Science Ltd. in Kudikadu Village, India, an Active Pharmaceutical Ingredient manufacturer, revealed significant deficiencies. The firm failed to adequately investigate the root causes of NDMA impurities in Ranitidine and Nizatidine APIs, did not properly validate cleaning procedures, and exhibited issues with laboratory instrument calibration and analytical method validation. These observations indicate a lack of robust quality oversight and control over critical manufacturing and testing processes.