FDA 483 - Steven (NMI) Zeig, MD - March 16, 2015

An FDA inspection of Steven Zeig, M.D., Clinical Investigator, revealed significant deviations from the investigational plan and protocol. Observations included the enrollment of subjects who met exclusion criteria without proper waivers and the administration of study drug by unauthorized personnel. These findings indicate a lack of adherence to study protocols and proper oversight in clinical investigations.