FDA EIR - Cedars-Sinai Medical Center IRB - April 18, 2016

An FDA routine surveillance inspection of Cedars-Sinai Medical Center IRB in Los Angeles, CA, was conducted from April 12-18, 2016. This pre-announced inspection, performed under Compliance Program 7348.809 for Institutional Review Boards, aimed to evaluate the IRB's adherence to regulatory standards. The inspection team reviewed comprehensive aspects of the IRB's operations, including membership, meeting minutes, written procedures, significant and non-significant risk device determinations, documentation of initial and continuing research review, reporting requirements, expedited and emergency review processes, and informed consent. The facility had recently relocated to a new address prior to the inspection. Cedars-Sinai Medical Center IRB oversees numerous active studies, with a substantial portion being FDA-regulated drug and device studies spanning specialties such as cancer, cardiology, and neuroscience. Importantly, the inspection found no discrepancies or problems in the IRB's records or practices. As a result, an FDA 483, Inspectional Observations, was not issued, indicating that the Cedars-Sinai Medical Center IRB was found to be operating in compliance with applicable regulatory requirements during the inspection period. Therefore, no specific corrective actions were required by the FDA.