FDA 483 - Dakhil, Dr Shaker - May 10, 2021

An FDA inspection of Shaker R. Dakhil, MD, a clinical investigator in Wichita, KS, revealed two significant observations. The firm failed to conduct an investigation in accordance with the investigational plan, specifically regarding documentation of investigational product dosing and timely reporting of a serious adverse event. Additionally, the firm did not maintain adequate case histories, as several adverse events were not reported in the electronic case report forms.