FDA WARNING_LETTER - Senthil Specialty Hospital - January 24, 2025

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Purushothaman Damodara Kumaran, M.D., associated with Senthil Specialty Hospital in Pondicherry, Puducherry, India, following an inspection from January 20-24, 2025. The inspection reviewed the conduct of a clinical bioequivalence study for an investigational drug. The FDA found objectionable conditions indicating non-adherence to the Federal Food, Drug, and Cosmetic Act and regulations outlined in 21 CFR Part 312, concerning clinical investigations and human subject protection. The primary violation was Dr. Kumaran's failure to ensure the investigation was conducted according to the investigational plan. Specifically, required weekly safety assessments, including hematology and pulmonary function tests for subjects receiving the investigational drug, were not completed for multiple subjects during crucial periods. The protocol mandated these assessments to monitor for serious adverse events like myelosuppression and pulmonary toxicity. Dr. Kumaran's response, citing pragmatic reasons for modifying the schedule, was deemed inadequate as it lacked evidence of sponsor approval or details on future corrective actions. The FDA emphasized the critical responsibility of clinical investigators to protect subject safety and ensure data integrity. Dr. Kumaran must notify the FDA within 15 business days of actions taken to prevent similar violations in ongoing and future studies.