FDA 483 - David Scott - March 24, 2010

An FDA inspection of David F. Scott, M.D., Clinical Investigator in Spokane, WA, revealed multiple significant deviations from clinical trial protocols and regulatory requirements. The firm failed to ensure subjects met inclusion/exclusion criteria, did not perform required laboratory tests and physical examinations, and conducted study procedures before obtaining informed consent. Additionally, the inspection found issues with unapproved changes to research activities, inadequate case histories, and insufficient investigational drug disposition records.