FDA 483 - Sun Pharmaceutical Industries Ltd. - June 13, 2025

An FDA inspection of Sun Pharmaceutical Industries Ltd. in Halol, Gujarat, revealed critical deficiencies in aseptic processing and quality control, many of which were repeat observations from a previous Warning Letter. The firm failed to prevent microbiological contamination of sterile drug products, adequately validate aseptic processes, and thoroughly investigate discrepancies. These issues led to potential product quality concerns, including metal particulate contamination and the distribution of failing batches.