FDA 483 - Michael L. Levin, M.D. - November 25, 2020

An FDA inspection of Michael L. Levin, M.D. in Las Vegas, NV, a clinical investigator, revealed significant deviations from the investigational plan and inadequate record-keeping. The firm failed to conduct required safety calls and study visits within protocol windows, potentially jeopardizing subject safety. Additionally, issues were noted with staff delegation, laboratory freezer monitoring, review of subject eligibility labs, and the submission of adverse events and concomitant medications to the electronic data capture system.