FDA 483 - Joel Vandersluis, M.D. - August 12, 2022

An FDA inspection of Joel Vandersluis, M.D. in Dayton, OH, a clinical investigator, revealed one observation related to the conduct of an investigation. The firm failed to conduct an investigation in accordance with the signed statement of investigator, specifically by not adding a facility performing MRI and PET scans to the Form FDA 1572 in a timely manner. This indicates a lapse in adherence to study protocol and regulatory documentation requirements.