FDA 483 - Merrill D. Benson, M.D. - December 03, 2018

An FDA inspection of Merrill D. Benson, M.D., a Sponsor-Investigator in Indianapolis, revealed significant issues in conducting a clinical investigation. The firm failed to adhere to the investigational plan regarding platelet monitoring for study subjects and did not notify the FDA about a change in the Principal Investigator for a study. These issues were noted as repeat observations from a previous inspection.