FDA 483 - Opada Alzohaili, M.D. - March 29, 2016

An FDA inspection of Opada AlZohaili, M.D., a clinical investigator in Dearborn, MI, revealed two significant observations. The firm failed to properly document informed consent, specifically by not having subjects date consent forms. Additionally, the firm did not maintain adequate and accurate case histories, with discrepancies noted between electronic medical records and study team notes regarding subject inclusion criteria.