FDA 483 - Sun Pharmaceuticals Industries Ltd. - December 15, 2023

An FDA inspection of Sun Pharmaceutical Industries Limited in Dadra, India, a finished drug products manufacturer, revealed significant deficiencies across its quality systems. Observations included inadequate Out-of-Specification investigations, equipment contamination risks, and a lack of Quality Unit oversight on GMP documentation and logbook management. Furthermore, the firm failed to thoroughly investigate product quality complaints, neglected to submit required Field Alert Reports, and conducted insufficient annual examinations of reserve samples, indicating systemic GMP non-compliance.