FDA 483 - Raed Alalawi, M.D. - June 10, 2021

An FDA inspection of Raed Alalawi, M.D. in Phoenix, AZ, identified significant issues with the conduct of a clinical investigation. The firm failed to conduct the investigation in accordance with the signed statement of investigator and investigational plan, specifically regarding investigator-specific assessments. Additionally, there was inadequate oversight, leading to a clinical coordinator performing investigator assessments and subsequent deletion of source data.