FDA 483 - Muhammad Salman Ali Ashraf - May 16, 2019

An FDA inspection of Muhammad Salman Ali Ashraf, a clinical investigator in Springfield, OH, revealed significant deficiencies in the conduct of a clinical study. Observations included a lapse in IRB approval, failure to obtain informed consent from a majority of subjects, and multiple deviations from the investigational plan regarding screening labs, inclusion criteria, and adverse event reporting. These findings indicate serious non-compliance with regulatory requirements for human subject protection and clinical trial conduct.