Nancy Kim, M.D. – FDA 483, Mar 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.
ID · 745460e3-0f68-4b66-a1c0-5c3dcdb83709
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