FDA 483 - Wissam Abouzgheib, MD - January 29, 2018

During an FDA inspection conducted from January 25-29, 2018, at the clinical investigator site of Wissam Abouzgheib, MD, in Camden, NJ, a significant observation was made. The inspection revealed that a clinical investigation was not conducted in adherence to the signed agreement and approved protocol. Specifically, the investigator failed to exclude a subject, ORA13_01_005, from a study despite the subject meeting pre-defined exclusion criteria. This subject was randomized into the study and received the investigational device, constituting a deviation from the study protocol. This action occurred without the required prior review and approval from both the Institutional Review Board (IRB) and the study sponsor. The regulatory framework requires clinical investigators to conduct trials in compliance with the protocol agreed to by the sponsor, the IRB, and the FDA, and to obtain prior approval for any protocol deviations. The FDA Form 483 serves as a notification of these inspectional observations, which do not constitute a final determination of compliance. Wissam Abouzgheib, MD, is expected to review these observations and provide a response outlining corrective actions implemented or planned to address the identified issues and ensure future adherence to regulatory guidelines for clinical investigations.