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Inspections, Compliance, Enforcement, and Criminal Investigations
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Regulatory Procedures Manual
The Regulatory Procedures Manual is a reference manual for FDA personnel. It provides FDA personnel with information on internal procedures to be used in processing domestic and import regulatory and enforcement matters. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public.
We have recently redesigned the FDA Web Site. As a result, some Web links (URLs) embedded within guidance documents are no longer valid. If you find a link that does not work, please try searching for the document using the document title. For more assistance, go to Contact FDA.
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RPM Table of Contents
- Introduction (PDF - 21KB)
- Chapter 1 - Regulatory Organization (PDF - 266KB)
- Chapter 2 - FDA Authority (PDF - 236KB)
- Chapter 3 - Commissioning and Work Sharing (PDF - 539KB)
- Chapter 4 - Advisory Actions (PDF - 221KB)
- Chapter 5 - Administrative Actions (PDF - 640KB)
- Chapter 6 - Judicial Actions (PDF - 785KB)
- Chapter 7 - Recall Procedures (PDF - 318KB)
- Chapter 8 - Emergency Procedures (PDF - 108KB)
- Chapter 9 - Import Operations and Actions (PDF - 474KB)
- Chapter 10 - Other Procedures (PDF - 137KB)
- Chapter 11 - Glossary (PDF - 132KB)
- Appendix (PDF - 21KB)
- Chapter Summary
- RPM News
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