《PDA Presentation 03-26-2016 M. Hernandez》.pdf

Parenteral Drug Association® Missouri Valley Chapter Miguel A. Hernandez Director, Compliance Branch FDA KANSAS CITY DISTRICT March 26, 2012 913-752-2101 FDA ORA Responsibilities • Inspecting regulated products and manufacturers • Analyzing samples of regulated products • Reviewing imported products offered for entry into the United States • Responding to public health emergencies FDA Office of Regulatory Affairs Mission: “Protecting consumers and enhancing public health by maximizing compliance of FDA regulated products and minimizing risk associated with those products.” “Protecting consumers” “maximizing compliance” “regulated products” “minimizing risk associated with those products” FDA Office of Regulatory Affairs Mission: “Protecting consumers and enhancing public health by maximizing compliance of FDA regulated products and minimizing risk associated with those products.”