FDA 483 - Paul Harmatz, M.D. - October 16, 2020

An FDA inspection of Paul Harmatz, M.D. in Oakland, CA, a clinical investigator, revealed a significant issue with informed consent documentation. The inspection found that written informed consent forms were not properly signed by subjects or their legally authorized representatives, including instances where ad hoc translations were used without proper signatures or witness attestations. This indicates a failure to adhere to proper clinical trial documentation practices.