Steven David, M.D. – FDA 483, Jan 8, 2018

An FDA inspection of Steven David, M.D. in Wayne, NJ, a sponsor investigator, revealed significant deficiencies in the conduct of clinical investigations. The observations primarily concern failures to maintain adequate and accurate subject records and Institutional Review Board correspondences, report adverse events promptly to the FDA, and retain required study records for the specified duration. These issues indicate a serious lack of adherence to regulatory requirements for clinical trials.