FDA 483 - Bernard H. Doft, M.D. - September 28, 2012

An FDA inspection of Bernard H. Doft, M.D. in Pittsburgh, PA, a clinical investigator, revealed significant deficiencies in the conduct of clinical investigations. Observations included failures to adhere to the investigational plan, maintain accurate case histories, and properly obtain informed consent from human subjects. These findings indicate serious non-compliance with regulatory requirements for clinical trials.