FDA 483 - Samer Kazziha MD - July 31, 2020

Samer Kazziha MD, a clinical investigator in Sterling Heights, MI, was cited for significant deficiencies related to an investigational trial. The inspection revealed failures in ensuring research participants received critical study updates and new risk information, as well as a failure to report a study hold to the Institutional Review Board (IRB). These issues indicate a lack of adherence to the investigational plan and IRB requirements.