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

An FDA Establishment Inspection of Richard E. Ringel, MD, a Sponsor-Investigator based in Baltimore, Maryland, took place from December 14-17, 2015. This high-priority, pre-approval inspection, conducted under compliance programs for Clinical Investigators and Sponsors, aimed to verify adherence to an investigational device study protocol (IDE# supporting PMA P150028) and compliance with federal regulations and Good Clinical Practices. The inspection uncovered a critical repeat violation: Dr. Ringel's failure to conduct the study in accordance with the signed agreement and investigational plan. Specifically, adverse events for one subject were not fully recorded in the electronic Case Report Forms (eCRFs) and consequently not reported to the FDA. Furthermore, the site failed to properly follow up on two subjects who missed study visits, including one classified as lost to follow-up, without documented attempts to contact them as required by the protocol. This mirrors a previous 2009 inspection and subsequent Warning Letter. While other prior deficiencies, such as overall monitoring across sites and obtaining investigator agreements, were corrected, the core issues of adverse event reporting and subject accountability persist. Dr. Ringel acknowledged the observations and committed to submitting a written corrective and preventive action plan, discussing findings with study staff, and ensuring comprehensive training. The FDA investigator stressed the importance of implementing robust quality control and ensuring adequate monitoring to prevent future non-compliance, noting potential enforcement actions for unresolved issues.