FDA 483 - Kyle Coleman, M.D. - March 20, 2019

An FDA inspection of Kyle M. Coleman, MD, PI, a clinical investigator in New Orleans, LA, conducted from March 18-20, 2019, identified a significant deficiency in investigational drug disposition records. The firm failed to maintain adequate records regarding the dates and quantities of investigational drug product returned by subjects. This indicates a lack of proper accountability for investigational products during the clinical trial.