FDA 483 - Marc A. Bjurlin, D.O. - July 22, 2024

The FDA inspected Marc A. Bjurlin, D.O. at UNC Hospitals Urology Clinic in Chapel Hill, NC, regarding a clinical investigation. The inspection revealed that the study was not conducted according to the investigational plan, specifically failing to perform protocol-required assessments for enrolled subjects. This indicates a significant deviation from the approved study protocol.