ANTHEM BIOSCIENCES PRIVATE LIMITED - Phase II – FDA 483, Dec 8, 2022

Anthem Biosciences Private Limited in Ramnagar, Karnataka, was cited for significant deficiencies in its quality systems, facilities, and production controls during an FDA inspection. The inspection revealed inadequate investigations into failures, poor water system control, lack of quality unit oversight for supplier qualification, and insufficient cleaning validation for manufacturing equipment. Additionally, the facility's cleanrooms were not adequately maintained, and process validation for drug substance manufacturing was found to be deficient.