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Inspection References
Investigations Operations Manual 2004 Cover Page
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Inspections Operations Manual 2004
	Department of Health and Human Resources
	Food and Drug Administration
	Office of Regulatory Affairs
	Office of Regional Operations
	Division of Field Investigations
	with image of Magnifying Glass and Badge 
	in prominent display signifying the 
	investigational nature of the content. IOM Chapter 1 [PDF PDF Document, 652 KB]
IOM Chapter 2 [PDF PDF Document, 259 KB]
IOM Chapter 3 [PDF PDF Document, 489 KB]
IOM Chapter 4 [PDF PDF Document, 4.3 MB]
IOM Chapter 5 [PDF PDF Document, 4.0 MB]
IOM Chapter 6 [PDF PDF Document, 569 KB]
IOM Chapter 7 [PDF PDF Document, 1.6 MB]
IOM Chapter 8 [PDF PDF Document, 300 KB]
IOM Chapter 9 [PDF PDF Document, 4.3 MB]
IOM Chapter 10 [PDF PDF Document, 189 KB]
IOM Appendix A [PDF PDF Document, 337 KB]
IOM Appendix B [PDF PDF Document, 402 KB]
IOM Appendix C-H [PDF PDF Document, 1.3 MB]

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 2004 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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