FDA 483 - Bankole Johnson MD - October 28, 2020

An FDA inspection of James William Woodlee, Partner Kleinfeld, Kaplan, & Becker, LLP, a clinical investigator in Charlottesville, VA, revealed significant deficiencies in clinical trial conduct. Observations included inadequate drug disposition records, numerous protocol deviations in subject management and data collection, failures in IRB continuing review submissions, and lack of required financial disclosure statements. These issues indicate a serious lack of oversight and adherence to regulatory requirements in clinical investigations.