FDA 483 - Somerset Therapeutics Limited - February 21, 2025

An FDA inspection of Somerset Therapeutics Private Limited in Bengaluru, India, revealed critical deficiencies in their manufacturing of sterile drug products. The firm failed to submit field alert reports for bacteriological contamination, conducted inadequate investigations into product discrepancies, and exhibited significant lapses in aseptic processing validation and environmental controls. These issues indicate a lack of robust quality systems, potentially compromising the sterility and quality of drug products distributed in the U.S. market.