About the Office of Regulatory Affairs
The FDA’s Office of Regulatory Affairs is the lead office for all FDA Field activities as well as providing FDA leadership on imports, inspections, and enforcement policy. ORA supports the six FDA Product Centers by inspecting regulated products and manufacturers, conducting sample analysis on regulated products, and reviewing imported products offered for entry into the United States. ORA also develops FDA-wide policy on compliance and enforcement and executes FDA’s Import Strategy and Food Protection Plans.
ORA staff are dispersed throughout the United States. Over 85 percent of ORA’s staff works in 5 Regional Offices, 20 District Offices, 13 Laboratories, and more than 150 Resident Posts and Border Stations. ORA Headquarters is comprised of the Office of Resource Management; Office of Regional Operations; and, the Office of Enforcement located in Rockville, Maryland and the Office of Criminal Investigations located throughout the United States. FDA maintains offices and staff in Washington, D.C., the U.S. Virgin Islands, Puerto Rico, and in all States except Wyoming.
Besides executing its mission through its Federal workforce, ORA also works with its State, Local, Tribal, and Territories counterparts to further FDA’s mission. ORA funds grants and cooperative agreements to perform State inspections and provide technical assistance to the States in such areas as milk, food, and shellfish safety.