FDA 483 - Joel Schlessinger, M.D. - December 12, 2019

An FDA inspection of Joel Schlessinger, M.D., a clinical investigator in Omaha, NE, revealed a significant failure to report adverse effects. The firm did not document adverse events, which were deemed probably related to investigational products, in the electronic data capture system for multiple subjects. This indicates a serious lapse in clinical trial oversight and reporting.