FDA EIR - Rajendra R. Makkar, MD - April 15, 2016

An FDA inspection of Rajendra R. Makkar, MD, a clinical investigator associated with Cedars Sinai Medical Center in Los Angeles, California, was conducted from April 11 to April 15, 2016. This preannounced inspection, carried out under the Bioresearch Monitoring Compliance Program (CP 7348.811 – Clinical Investigator Data), focused on an IDE-based clinical study designed to evaluate the safety and effectiveness of a medical device in a vulnerable patient population. The inspection reviewed comprehensive documentation, including subject records, informed consent forms, regulatory binders, and adverse event reports. The inspection concluded without identifying any serious violations and, notably, no FDA-483 Inspectional Observations were issued. However, two items were discussed with the firm for clarification. Firstly, an adverse event related to bleeding from a procedure site, reported on May 12, 2014, was not formally signed by Dr. Makkar until October 22, 2014. The site explained this delay was due to their process of electronic entry followed by later physical signing. Secondly, baseline screening procedures, specifically ECHO and EKG, were performed on a subject prior to the signing of the Informed Consent Form. The site clarified that these were standard clinical evaluations for a commercially available stent, not study-specific procedures, and all study-related interventions occurred post-consent. These points were reviewed and addressed during the closeout meeting with Dr. Makkar and his research coordinator.