FDA 483 - Akindele E. Kolade, M.D. - May 06, 2019

Akindele Kolade, M.D., a clinical investigator in Las Vegas, NV, was inspected regarding bioresearch monitoring. The inspection revealed significant deficiencies in the conduct of a study, including the enrollment of subjects who did not meet inclusion/exclusion criteria and the failure to complete required laboratory and safety assessments as per the study protocol. These issues indicate a failure to conduct the investigation in accordance with the signed statement of the investigator.