FDA 483 - Steven W. Pipe, M.D. - October 24, 2022

An FDA inspection of Steven W. Pipe, M.D. in Ann Arbor, MI, a clinical investigator, revealed significant issues related to human subject protection and record-keeping. The firm failed to obtain proper informed consent from a human subject prior to study-related activities and did not maintain adequate case histories, including missing original consent forms and incomplete electronic correspondence.