FDA 483 - Karim Chamie, M.D. - December 14, 2022

Karim NMI Chamie, MD, a Clinical Investigator in Los Angeles, CA, was cited for failing to conduct an investigation in accordance with the investigational plan. The inspection revealed significant deviations, including the enrollment of ineligible subjects and the failure to perform required biopsies and collect cytology samples for multiple subjects. These issues indicate a serious lack of adherence to study protocol and data collection requirements.