FDA EIR - David A. Heimansohn, M.D. - December 20, 2019

A routine, high-priority FDA inspection was conducted at David A. Heimansohn, M.D., Indianapolis, IN, from December 16-20, 2019. The inspection focused on Dr. Heimansohn's role as Principal Investigator for a medical device Premarket Approval (PMA) protocol, in accordance with Compliance Program 7348.811 for Clinical Investigators. The study involved 48 enrolled subjects for an investigational device. The inspection scope included verification of submitted data and PI oversight, reviewing subject informed consent documents, case report forms, medical histories, adverse events, Institutional Review Board approvals, sponsor monitoring, investigational product control, and adherence to the investigational plan and standard operating procedures. The primary effectiveness and safety endpoints for the reviewed subject records were found to be verifiable. Notably, a previous inspection in November 2016 resulted in a one-item FDA-483 observation related to the investigation not being conducted according to the signed agreement and investigational plan. This previous issue was classified as Voluntary Action Indicated (VAI), and follow-up was completed, with Dr. Heimansohn implementing additional staff training as a corrective measure. For the current inspection, no main violations or objectionable conditions were identified. Consequently, no FDA-483 Inspectional Observations were issued at its conclusion. This indicates that the study was being conducted in a compliant manner, and no immediate regulatory actions were required from the FDA.