FDA 483 - Richard E. Ringel, M.D. - February 03, 2009

An FDA inspection of Richard E. Ringel, M.D., a sponsor-investigator in Baltimore, revealed significant deficiencies in the conduct and oversight of an investigational clinical study for a medical device. The inspection found a lack of proper study monitoring, non-compliance with the investigational plan, and failure to obtain required signed agreements from participating investigators regarding supervision, informed consent, and financial disclosure. Additionally, the sponsor-investigator failed to submit current lists of investigators to the FDA at required intervals.