FDA 483 - Sun Pharmaceutical Industries Limited - August 12, 2022

An FDA inspection of Sun Pharmaceutical Industries Limited in Mohali, India, a drug manufacturer, revealed significant deficiencies across multiple areas. The firm failed to thoroughly investigate discrepancies, including allegations of backdating and confirmed cross-contamination, and exhibited widespread non-contemporaneous documentation practices. Additionally, the inspection found inadequate written procedures for process control, laboratory records, and component testing, indicating a systemic lack of robust quality control and data integrity.