FDA 483 - Andrew R. Gould, M.D. - August 08, 2019

An FDA inspection of Andrew R. Gould, M.D., Clinical Investigator in Louisville, KY, revealed a significant lapse in subject protection. A vulnerable subject, identified as a ward of the state, was enrolled in an investigational study and underwent procedures without the necessary Institutional Review Board (IRB) approval. This indicates a serious failure to safeguard the rights and welfare of study participants.