FDA 483 - Ashwani K. Singal, M.D. - September 28, 2018

An FDA inspection of Ashwani K. Singal, M.D. in Hoover, AL, a clinical investigator, revealed a significant deficiency in the conduct and supervision of an investigational study. The firm failed to ensure subjects met protocol-required inclusion/exclusion criteria before enrollment and administration of investigational product. This indicates a serious deviation from the investigational plan and investigator responsibilities.