FDA 483 - Kailash K. Jindal, MD, PI - June 27, 2014

An FDA inspection of Kailash K. Jindal, MD, PI, a clinical investigator in Edmonton, Alberta, revealed significant deviations from the investigational plan. Observations included failure to withhold study drug when subjects were prescribed antibiotics/antifungals and enrollment of a subject with an active bacterial infection, both contrary to protocol requirements. These issues indicate a lack of adherence to study protocols during the clinical investigation.