Inspections, Compliance, Enforcement, and Criminal Investigations
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Investigations Operations Manual
| The IOM is the primary guidance document on FDA inspection policy and procedures for field investigators and inspectors. Important disclaimer: The IOM Adobe pdf by chapter files provided represent a duplicate of the HARDCOPY 2012 IOM content. Be aware that the pdf files have not been updated although these files may be updated in the future. The IOM html version shown in the left navigation area is the most current version. 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 As a result, some Web links (URLs) embedded within guidance documents are no longer valid.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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IOM PDF Version
Foreword (PDF - 39KB)Vision / Mission / Values (PDF - 23KB)- Table of Contents (PDF - 21KB)
Chapter 1 - Administration (PDF - 226KB)Chapter 2 - Regulatory (PDF - 314KB)Chapter 3 - Federal and State Cooperation (PDF - 171KB)Chapter 4 - Sampling (PDF - 823KB)Chapter 5 - Establishment Inspections (PDF - 2.5MB)Chapter 6 - Imports (PDF - 814KB)Chapter 7 - Recall Activities (PDF - 451KB)Chapter 8 - Investigations (PDF - 1.8MB)IOM Appendix (PDF - 448KB)IOM Index (PDF - 241KB)IOM ORA Directory (PDF - 294KB)IOM Sample Schedules (PDF - 152KB)
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