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Talk to a SpecialistTalk to a SpecialistLupin Limited's drug manufacturing facility in India was found to produce adulterated active pharmaceutical ingredients (APIs) due to significant current good manufacturing practice (CGMP) violations. The FDA identified failure to establish adequate written procedures for cleaning equipment and its release for use, with particular concern that cleaning procedures lacked sufficient data to demonstrate effective removal of genotoxic impurities and cross-contamination residues from non-dedicated production equipment to acceptable levels. The company's April 2022 response to the FDA's inspection findings was deemed inadequate because it failed to provide sufficient detail or evidence of corrective actions necessary to bring operations into compliance with CGMP requirements.