FDA 483 - Shaji K. Kumar, M.D. - June 20, 2025

An FDA inspection of Mayo Clinic in Rochester, MN, identified significant issues related to the conduct of an investigational study. Observations included failures to adhere to the investigational plan and protocols, specifically regarding the capture and reporting of serious adverse events. Additionally, the firm failed to retain required investigational records for the specified period, with numerous source documents found missing.