FDA 483 - Somerset Therapeutics Limited - April 04, 2022

An FDA inspection of Somerset Therapeutics Limited in Bangalore, India, revealed significant deficiencies in their sterile drug manufacturing processes. The firm failed to adhere to procedures preventing microbiological contamination, exhibited a deficient environmental monitoring program, and conducted inadequate investigations into product discrepancies and out-of-specification results. These findings, including repeat observations, indicate serious concerns regarding the quality control unit's oversight and aseptic processing practices.