FDA 483 - Scott Okuno, M.D. - February 28, 2020

The FDA inspected Mayo Clinic Cancer Center in Rochester, MN, and issued a Form 483 citing significant failures in conducting an investigation according to the signed statement of investigator and investigational plan. Observations included multiple instances of protocol deviations, unreported procedures, unreported concomitant medications, and unreported adverse events. These findings indicate a lack of adherence to study protocols and reporting requirements during clinical trial conduct.