FDA 483 - Michael J Rosen MD - March 01, 2023

The FDA inspected Cleveland Clinic Found, a principal investigator site in Cleveland, OH, from February 14 to March 1, 2023. The inspection revealed that serious adverse events (SAEs) were not reported to the sponsor within the protocol-required 24-hour timeframe for multiple subjects. This indicates a failure to conduct the investigation in accordance with the signed agreement and investigational plan.