FDA 483 - Richard E. Ringel, M.D. - December 17, 2015

An FDA inspection of Richard E. Ringel, M.D. in Baltimore, MD, from December 14-17, 2015, revealed significant deviations from an investigational plan and study protocol. The firm failed to properly record adverse events for study subjects and did not maintain adequate subject accountability, including follow-up for missed visits and documentation for subjects lost to follow-up. These findings indicate serious issues in the conduct and oversight of clinical investigations.