Inspections, Compliance, Enforcement, and Criminal Investigations
Resources for You
Application Integrity Policy Bioresearch Monitoring [Retired Page] Disqualified/Restricted/Restrictions Removed/Assurance Lists for Clinical Investigators Current Good Manufacturing Practices (cGMP) for Drugs: Reports, Guidances and Additional Information FDA Debarment List (Drug Product Applications) Public Health Service Administrative Actions Listing ORA FOIA Electronic Reading Room
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This page provides links to documents, lists, policies, programs, and statements relating to Compliance References used by FDA personnel:
- Federal Food, Drug, and Cosmetic Act, FDA Regulations and Additional laws enforced by the FDA Code of Federal Regulations - Title 21
- Compliance Program Guidance Manual (CPGM)
Compliance programs (program plans and instructions) directed to field personnel.
- Compliance Policy Guides (CPG)
Contains FDA compliance policy and regulatory action guidance for FDA staff.
- Regulatory Procedures Manual (RPM)
Contains FDA regulatory procedures for use by FDA personnel. A reference document for enforcement procedures and practices.
- Staff Manual Guides (SMG)
The Agency directives that document organizations and functions, delegations of authority, general administrative operations, and programs of the FDA.