FDA 483 - Bruce G. Redman, D.O. - January 11, 2019

Bruce G. Redman, D.O., a clinical investigator in Ann Arbor, MI, was cited for failing to conduct an investigation in accordance with the signed statement of investigator and investigational plan. Specifically, a study subject was provided with an incorrect medication for six weeks, resulting in significant adverse health effects including increased TSH levels, headaches, and an elevated oncology score. This indicates a serious deviation from study protocol and potential patient safety concerns.