483
Northfelt, Donald MDNorthfelt, Donald MD – FDA 483, Dec 14, 2018
Record Details
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.
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