FDA 483 - Somerset Therapeutics Limited - April 04, 2022
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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.
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