About FDA
FDA-TRACK Office of Regulatory Affairs
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The FDA’s Office of Regulatory Affairs (ORA) is the lead office for all FDA field activities as well as providing FDA leadership on imports, inspections, and enforcement policy. ORA supports the 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.
FDA-TRACK ORA Program Areas and Offices
ORA has six program areas for nine offices and 13 laboratories. Click on the links below for additional information relating to these program areas and dashboards.
FDA-TRACK ORA Laboratories This page includes ORA's 13 laboratories. FDA-TRACK ORA Associate Commissioner of Regulatory Affairs Dashboard This page includes the Office of Associate Commissioner for Regulatory Affairs. FDA-TRACK ORA Office of Criminal Investigations This page includes the Office of Criminal Investigations (OCI). - FDA-TRACK ORA Office of Enforcement
This page includes the Office of Enforcement (OE). FDA-TRACK ORA Regional Offices This page includes the Office of Regional Operations (ORO) and ORA's five regional field offices. FDA-TRACK ORA Resource Management This page includes the Office of Resource Management (ORM).
Additional Information on ORA
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FDA-TRACK Team
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