FDA 483 - Joseph M.B. Croffie, MD - March 16, 2018

An FDA inspection of Joseph M.B. Croffie, M.D., a clinical investigator in Indianapolis, IN, revealed significant deficiencies in the conduct of an investigation. Observations included failures to adhere to the investigational plan, specifically regarding documentation of subject inclusion/exclusion criteria and proper reporting of adverse events. Additionally, the firm was cited for inadequate and inaccurate case histories, with notable discrepancies in investigational drug disposition records.