FDA 483 - Syed Jamal Mustafa, M.D. - May 31, 2019
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · d2bb2615-afae-455e-8c7e-39af051bf3d7