FDA 483 - Sun Pharmaceutical Industries Limited - February 07, 2020

An FDA inspection of Sun Pharmaceutical Industries Limited in Mohali, India, revealed a significant issue with drug product testing. The firm failed to appropriately test batches of non-sterile drug products for objectionable microorganisms, specifically using unvalidated methods for method suitability tests. This indicates a serious lapse in quality control for products shipped to the United States market.