FDA 483 - Brian I Rini MD - January 25, 2019

An FDA inspection of Brian I Rini MD in Cleveland, OH, a clinical investigator site, revealed significant deficiencies in the reporting of adverse events and adherence to investigational plans. The firm failed to promptly report a serious adverse event to the sponsor and did not report numerous non-serious adverse events or concomitant medications as required by the study protocol. These findings indicate a serious lack of oversight in clinical trial conduct.