483
Kennedy, Philip R.Kennedy, Philip R. – FDA 483, Oct 16, 2019
Record Details
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.
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ID · 0a5abf4a-390b-44a5-9299-e4a8fde07481
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