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Inspections, Compliance, Enforcement, and Criminal Investigations

FDA's Office of Regulatory Affairs (ORA) - working to keep your community safe.

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Regulatory Science and Innovation

ORA News, Stories, and Features

Our vision. Our people. Our everyday efforts to keep you safe. Connect to the latest news, perspectives, and stories from staff.

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You Can Help

Report a Problem to the FDA

Consumers play an important role in public health by reporting to FDA any adverse reactions or other problems with products the agency regulates

Report Suspected Criminal Activity

If you wish to report suspected criminal activity relating to FDA regulated products, please describe the suspected criminal activity in detail to the Office of Criminal Investigation

About the Office of Regulatory Affairs

The U.S. Food and Drug Administration’s Office of Regulatory Affairs (ORA) is the lead office for all agency field activities. ORA inspects regulated products and manufacturers, conducts sample analyses of regulated products and reviews imported products offered for entry into the United States. In pursuit of its mission, ORA also works with its state, local, tribal, territorial and foreign counterparts.


Compliance Manuals

Official documents, lists, policies, programs, and statements relating to Compliance References used by FDA personnel

Inspection References

Information provided to assist FDA investigators and inspectors in their daily activities

Criminal Investigations

Information, news and contact information related to FDA's Criminal Investigation Activities

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