FDA 483 - David R. Greeley, MD - March 25, 2022

An FDA inspection of David R. Greeley, MD in Spokane, WA, revealed significant deficiencies in the conduct of clinical investigations for Alzheimer's Disease drug studies. The firm failed to adhere to investigational plans, including dosing subjects with unresolved adverse events and not reporting adverse events from MRI findings in a timely or accurate manner. Additionally, the firm did not maintain adequate and accurate case histories, specifically regarding the documentation of sedation medications for subjects undergoing MRIs.