FDA 483 - Khaled Tawansy, MD - August 24, 2022

An FDA inspection of Khaled Tawansy, MD, a clinical investigator in Los Angeles, CA, revealed a significant issue regarding the conduct of an investigation. The Principal Investigator failed to provide adequate oversight of study site personnel. This led to uncertified Clinical Research Coordinators performing protocol-specific assessments, which was not in accordance with the investigational plan.