FDA 483 - Lee G. Rosen, MD, Principal Investigator - February 08, 2017

An FDA inspection of Lee G. Rosen, MD, Principal Investigator, identified a significant deviation in the conduct of a clinical investigation. The firm failed to ensure that only authorized and trained personnel prepared investigational product for subjects, contrary to the signed statement of investigator and delegation of duties log. This lapse raises concerns about adherence to study protocol and patient safety.