FDA 483 - Kennedy, Philip R. - October 16, 2019

Philip R. Kennedy, M.D., PhD, Sponsor-Investigator, was inspected regarding an investigational device study and received nine observations. The inspection revealed significant deficiencies in IRB oversight, study monitoring, informed consent, device accountability, adverse event reporting, record keeping, and financial disclosure for sub-investigators. Several observations were repeats from a prior inspection, indicating persistent non-compliance.