FDA 483 - Sukit Christopher Malaisrie, M.D. - September 04, 2019

Dr. Sukit Christopher Malaisrie, a Clinical Investigator in Chicago, IL, was inspected by the FDA from August 19 to September 4, 2019. The inspection revealed two significant issues related to the protection of human subjects and investigational device studies. Specifically, deficiencies were noted in obtaining informed consent prior to an investigational device implant and in the timely reporting of an unanticipated adverse device effect to the Institutional Review Board (IRB).