US FDA Office of Regulatory Affairs
12420 Parklawn Drive
The Food and Drug Administration (FDA) is the regulatory, scientific, public health, and consumer protection agency responsible for ensuring that all human and animal drugs, and medical devices are safe and effective, that cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, and radiation emitting devices are safe, and that all such products marketed in the United
States are adequately, truthfully and informatively labeled and safely and properly stored, transported, manufactured, packaged and regulated. FDA’s programs are national in scope and effect, and the agency’s activities have a direct and significant impact on multi-billion-dollar industries, in addition to protecting the health and safety of American Consumers. The work of the Agency is carried out by a staff of more than 18,000 scientists, physicians, regulatory and other personnel stationed throughout the United States and abroad.
The Office of Regulatory Affairs (ORA) is at the forefront of building a public health safety net for today’s complex, global regulatory environment. ORA professionals work in a range of program areas and locations, with 227 offices and 13 laboratories throughout the United States. As the lead office for all FDA field activities, ORA serves as the agency’s direct connection with regulated industry through a) inspections of firms and plants producing FDA-regulated products, b) investigations of consumer complaints, emergencies and criminal activity, c) enforcement of FDA regulations, d) sample collection and analysis, and e) review of imported products.
To view our ORA Vision, Mission, and Values please visit: https://www.fda.gov/about-fda/office-regulatory-affairs/ora-vision-mission-and-values.
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