Inspections, Compliance, Enforcement, and Criminal Investigations
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.
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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)