FDA 483 - P. Damodara Kumaran, M.D. - January 24, 2025

An FDA inspection of P. Damodara Kumaran, M.D., a clinical investigator in Pondicherry, Puducherry, revealed significant deviations from investigational plans and regulatory requirements. The firm failed to conduct investigations according to the signed statement of investigator and protocol, leading to missed subject visits and procedures. Additionally, the firm did not maintain adequate and accurate case histories, including missing laboratory results, submitting inaccurate data to the CRO and FDA, and lacking proper audit trails for electronic lab data.