FDA 483 - Samer K. Khaled, M.D. - December 23, 2020

The FDA inspected Samer K. Khaled, M.D., a clinical investigator in Duarte, CA, from December 17-23, 2020. The inspection revealed deficiencies in the timely reporting of adverse events and the maintenance of adequate case histories. Specifically, one serious adverse event was not reported until prompted by a study monitor, and three other adverse events were not entered into the electronic data capture system in a timely manner.