483
Raed Alalawi, M.D.Raed Alalawi, M.D. – FDA 483, Jun 10, 2021
Record Details
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.
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