FDA 483 - E. Jeffrey Greenberg, MD - May 30, 2018

An FDA inspection of E. Jeffrey Greenberg, MD, a clinical investigator in Somerset, NJ, revealed two significant observations. The firm failed to conduct an investigation in accordance with its investigational plan, specifically regarding incorrect scoring of a test for study subjects. Additionally, the firm did not maintain adequate case histories, as multiple study notes for several subjects were not signed or dated by the individuals conducting the procedures.