Inspections, Compliance, Enforcement, and Criminal Investigations

Inspection References

This page includes information provided to FDA investigators and inspectors to assist them in their daily activities. It also includes links to the inspection references that were previously available on Gold Disk. For information on Gold Disk can be found at History of Gold Disk.

Manuals, Guides, and Other References

Resources used by FDA investigators and inspectors in their daily activities.

Manuals

  • Compliance Manuals

    FDA's Compliance Programs provide instructions to FDA personnel for conducting activities to evaluate industry compliance with the Federal Food, Drug, and Cosmetic Act and other laws administered by FDA. For tobacco related information please visit the tobacco guidance page.

    Includes documents, lists, policies, programs, and statements relating to Compliance References used by FDA personnel.
    • Compliance Program Guidance Manual (CPGM)

      Provides instructions to FDA personnel for conducting activities to evaluate industry compliance with the Federal Food, Drug, and Cosmetic Act and other laws administered by FDA.

    Provides FDA personnel with information on internal procedures to be used in processing domestic and import regulatory and enforcement matters. 

Investigations Operations Manual (IOM)

The IOM is the primary procedure manual for FDA personnel performing inspections and special investigations. 

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Guides

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Other References

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Regulatory Information

General History and Information Pertaining to FDA Regulations

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Page Last Updated: 04/24/2017
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