Chapter 1 - Administration [PDF 
,
318 KB]
Chapter 2 - Regulatory [PDF ,
533 KB]
Chapter 3 - Federal and State Cooperation [PDF ,
355 KB]
Chapter 4 - Sampling [PDF ,
1.1 MB]
Chapter 5 - Establishment Inspections [PDF ,
1.6 MB]
Chapter 6 - Imports [PDF ,
357 KB]
Chapter 7 - Recall Activities [PDF ,
104 KB]
Chapter 8 - Investigations [PDF ,
2.0 MB]
IOM Appendix [PDF ,
276 KB]
IOM Index [PDF ,
467 KB]
IOM ORA Directory [PDF ,
251 KB]
IOM Sample Schedules [PDF ,
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 2009 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.
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