FDA 483 - Sun Pharmaceutical Industries Limited - January 20, 2020

An FDA inspection of Sun Pharmaceutical Industries Limited, an API manufacturer in Ahmednagar, India, revealed deficiencies in the receiving controls for temperature-sensitive drug ingredients. The firm failed to provide adequate equipment and written procedures for temperature control, specifically by not verifying the temperature of incoming ingredients or data logger records from transporters. This indicates a lack of robust quality control over critical raw material receipt.