FDA 483 - Terry O'reilly, M.D. - August 22, 2013

An FDA inspection of Terry O'Reilly, M.D., a clinical research facility in Tempe, AZ, revealed a significant issue regarding the conduct of an investigation. The firm failed to adhere to the signed statement of investigator and investigational plan, specifically by enrolling and dosing subjects who met exclusion criteria. This indicates a failure to follow study protocols, which is a serious concern in clinical research.