FDA 483 - Bruno Carneiro De Medeiros, M.D. - April 29, 2016

An FDA inspection of Bruno C. de Medeiros, M.D. in Stanford, CA, revealed significant deficiencies in clinical trial conduct. The firm failed to maintain adequate and accurate case histories, including original source documents and proper informed consent. Additionally, investigations were not conducted according to the investigational plan, with issues such as failure to assess exclusion criteria, use of unapproved facilities, late SAE reporting, and incorrect study drug administration. Finally, investigational drug disposition records were inadequate, showing a substantial discrepancy in returned investigational product.