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Inspection References
Investigations Operations Manual 2008
Inspections Operations Manual 2008 Edition
Department of Health and Human Resources
Food and Drug Administration
Office of Regulatory Affairs
Office of Regional Operations
Division of Field Investigations
with images of FDA Badges IOM Chapter 1 [PDF PDF Document, 318 KB]
IOM Chapter 2 [PDF PDF Document, 533 KB]
IOM Chapter 3 [PDF PDF Document, 355 KB]
IOM Chapter 4 [PDF PDF Document, 1.1 MB]
IOM Chapter 5 [PDF PDF Document, 1.6 MB]
IOM Chapter 6 [PDF PDF Document, 357 KB]
IOM Chapter 7 [PDF PDF Document, 104 KB]
IOM Chapter 8 [PDF PDF Document, 2.0 MB]
IOM Appendix [PDF PDF Document, 276 KB]
IOM Index [PDF PDF Document, 467 KB]
IOM ORA Directory [PDF PDF Document, 251 KB]
IOM Sample Schedules [PDF PDF Document, 300 KB]

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 2008 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 is the most current version.

PDF files may be viewed with the free Acrobat Reader software from Adobe. If you do not have Acrobat Reader installed on your computer, download an accessible version of the Adobe Acrobat Reader plugin for your browser at: by selecting the "Get Acrobat Reader" button below.


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