FDA 483 - Northfelt, Donald MD - December 14, 2018

An FDA inspection of Donald W. Northfelt, MD, a clinical investigator in Phoenix, AZ, revealed that an investigation was not conducted in accordance with the investigational plan. Specifically, plasma samples for pharmacokinetic assessment were not collected for two subjects at specified timepoints, and related vital signs, labs, and concomitant medications were not completed or reported to the IRB.