FDA 483 - Clive Ballard, M.D. - May 20, 2022

An FDA inspection of Clive Ballard, M.D., a clinical investigator in London, revealed significant issues with the conduct of a clinical study. Observations included the enrollment of ineligible subjects due to failure to follow the investigational plan and a failure to obtain proper informed consent from human subjects prior to study procedures. These findings indicate deficiencies in adherence to study protocols and regulatory requirements for human subject protection.