FDA EIR - Mrinal M. Gounder, M.D. - March 03, 2023

An FDA inspection of Mrinal M. Gounder, M.D., a clinical investigator in New York, NY, was conducted from February 21 to March 3, 2023. This high-priority, for-cause assignment, initiated due to a complaint and a New Drug Application, followed the guidance of Compliance Program 7348.811 for Clinical Investigators. The inspection identified two significant violations, detailed in a Form FDA 483. First, the investigation was not conducted in adherence to the signed investigator statement and investigational plan, specifically noting over 600 protocol deviations across two studies that were not submitted to the Institutional Review Board (IRB) within required timeframes. Second, there was a consistent failure to promptly report serious adverse events (SAEs) and adverse events of special interest (AESIs) to the study sponsor as stipulated by protocol. Dr. Gounder committed to providing a written response to these observations. The site is currently working to resolve outstanding data queries from the sponsor and anticipates eventual study closure, with active subjects transitioning to single patient use of investigational products.