FDA 483 - Andre Kalil, M.D. - January 14, 2022

Andre C. Kalil, M.D., Clinical Investigator, was inspected in Omaha, NE, and cited for multiple deficiencies related to clinical trial conduct. The inspection revealed significant issues with informed consent procedures, including failure to obtain consent, providing consent in the wrong language, and improper documentation. Additionally, the investigator failed to provide adequate oversight of study staff and maintain accurate case histories.