Joseph M.B. Croffie, MD – FDA 483, Mar 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.
ID · 0d1b0f52-dfb6-47d2-8fee-2cf7f2b738a1
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