FDA 483 - Sun Pharmaceutical Medicare Limited - September 19, 2025

An FDA inspection of Sun Pharmaceutical Medicare Ltd. in Halol, India, revealed significant deficiencies in aseptic processing, environmental monitoring, and quality control investigations. The firm failed to prevent microbiological contamination of sterile drug products due to poor aseptic techniques, unvalidated sterilization cycles, and inadequate airflow controls. Furthermore, the facility exhibited a negative trend in environmental and personnel monitoring excursions and conducted insufficient investigations into contamination events, raising serious concerns about the sterility assurance of their products.