FDA 483 - John J. Wrenn, M.D. - April 15, 2024

John J. Wrenn, M.D., a clinical investigator in Greensboro, NC, was cited with two observations during an FDA inspection. The inspection revealed a lack of proper oversight over clinical research studies, specifically regarding investigational product accountability and the provision of regulatory documents. Additionally, investigational drug disposition records were found to be inadequate, with missing or incomplete subject accountability logs.