FDA 483 - Michael B. Jacobs, M.D. - December 20, 2022

Michael B. Jacobs, M.D. in Las Vegas, NV, was inspected for Bioresearch Monitoring and received a Form 483 with three observations. The inspection revealed significant issues including protocol deviations, failure to obtain proper informed consent for study procedures, and inadequate maintenance of case histories. These findings indicate a lack of adherence to regulatory requirements for clinical investigations.