FDA 483 - Syed Jamal Mustafa, M.D. - May 31, 2019

The FDA inspected Syed Jamal Mustafa, Principal Investigator, in Bothell, WA, regarding clinical trial conduct. The inspection revealed significant deviations from investigational plans and protocols, including the enrollment of ineligible subjects, delayed reporting of a serious adverse event, and improper administration of investigational product and physical examinations by unqualified personnel. These findings indicate a lack of adherence to established clinical trial regulations and internal procedures.