FDA EIR - Jihad A. Mustapha, MD - August 20, 2021

An FDA inspection was conducted at the clinical investigator site of Dr. Jihad A. Mustapha, MD, also known as Advanced Cardiac and Vascular Centers For Amputation Prevention, in Grand Rapids, MI. The inspection took place from August 17 to August 20, 2021. This routine inspection, requested by the Center for Devices and Radiological Health (CDRH) and guided by Compliance Program 7348.811 for Clinical Investigators, aimed to verify compliance with protocol and applicable regulations under an Investigational Device Exemption (IDE). The study involved a Premarket Approval (PMA) for a Drug-Eluting Below-the-Knee Vascular Stent System (Protocol #92193192). The inspection reviewed various aspects of the study, including informed consent, inclusion/exclusion criteria, adverse event reporting, IRB approvals, investigational product control, and data integrity practices. While a protocol deviation regarding reference vessel diameter (RVD) was noted for some early enrolled subjects, this issue was addressed internally by the sponsor and site, with retraining completed and protocol revised. Importantly, the FDA inspection concluded without any FDA-483 Inspectional Observations being issued, indicating no significant regulatory violations were identified. Consequently, no specific regulatory actions were required by the FDA at the conclusion of this inspection. The inspection report noted that documents were signed appropriately, neat, and orderly.