FDA 483 - Guenther Koehne, M.D. - January 10, 2024

An FDA inspection of Guenther Koehne, M.D. at Miami Cancer Institute revealed significant deviations in the conduct of a clinical investigation. The firm failed to follow the investigational plan, specifically by not reporting serious adverse events for multiple subjects and enrolling more subjects than permitted by the study protocol. These findings indicate serious non-compliance with clinical trial regulations.