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Intas Pharmaceuticals Limited's drug manufacturing facility in India was found to have violated current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, resulting in adulterated drug products. The FDA inspection from November-December 2022 identified critical failures in the quality control unit's oversight, including inadequate controls over CGMP documents, deficient computerized system controls, insufficient laboratory investigations, and data integrity deficiencies in production and laboratory departments. Senior facility managers failed to exercise proper authority and responsibility to ensure reliable data generation, demonstrating that the quality assurance function was not adequately performing its oversight role.