FDA WARNING_LETTER - Purushothaman Damodara Kumaran, M.D. - January 24, 2025

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Dr. Purushothaman Damodara Kumaran at Senthil Specialty Hospital following an inspection conducted between January 20 and 24, 2025, in Pondicherry, India. The inspection, part of the FDA’s Bioresearch Monitoring Program, focused on the conduct of a clinical bioequivalence study for an investigational drug. The agency determined that the investigator failed to adhere to the Federal Food, Drug, and Cosmetic Act and regulatory requirements under Title 21, Code of Federal Regulations, Part 312.

The primary violation was the failure to follow the established investigational plan. Dr. Kumaran omitted approximately half of the protocol-required safety assessments, including hematology and pulmonary function tests, for several study participants. These tests were critical for monitoring potential severe side effects associated with the drug, such as bone marrow suppression and lung toxicity. While Dr. Kumaran claimed the deviations were made for the convenience of the subjects and were supplemented by telephone monitoring, the FDA found this response inadequate due to a lack of documented evidence and failure to obtain prior sponsor approval for the changes.

To address these deficiencies, Dr. Kumaran is required to submit a written response within 15 business days. This response must detail specific corrective actions and procedures implemented to ensure that all current and future clinical investigations comply with FDA regulations. Failure to provide a sufficient remediation plan may lead to further regulatory action.