FDA 483 - Lyle Myers, M.D. - April 23, 2019

An FDA inspection of Lyle C. Myers, M.D., a clinical investigator in Lexington, KY, revealed significant deficiencies in clinical trial conduct. The firm failed to maintain adequate and accurate case histories by not documenting numerous hypoglycaemic events into the electronic case report forms (eCRF) as required by the study protocol. Additionally, the investigation was not conducted in accordance with the signed statement of the investigator and the investigational plan, specifically regarding the recording of self-monitored plasma glucose values and times.