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Inspections, Compliance, Enforcement, and Criminal Investigations

FDA's Office of Inspections and Investigations (OII) - working to keep your community safe.

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Regulatory Science and Innovation

OII 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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Recalls, Market Withdrawals, & Safety Alerts

Alerting you to the latest recalls of potentially unsafe FDA-regulated products gathered from press releases and other public notices. Not all recalls have press releases or are posted on this website.

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 Inspections and Investigations (OII)

The U.S. Food and Drug Administration’s Office of Inspections and Investigations (OII) is the lead office for all FDA field inspection, investigation, import and emergency response related activities. OII partners with internal and external agency stakeholders to identify, collect, and evaluate evidence that empowers integrated regulatory decision making. OII inspects regulated products and manufacturers, and reviews imported products offered for entry into the United States. In pursuit of its mission, OII also works with its state, local, tribal, territorial and foreign counterparts.

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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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