FDA 483 - Nancy Kim, M.D. - March 25, 2022

An FDA inspection of Nancy Kim, M.D., a clinical investigator in Scottsdale, AZ, revealed significant deviations from investigational plans and protocols. The investigator failed to personally conduct required study assessments, delegated duties to non-delegated staff, and allowed staff to use her login credentials for data entry. Additionally, the inspection found a dosing error involving an incorrect investigational product and a failure to report this and other dispensing errors to the sponsor in a timely manner.