2023 Investigations Operations Manual (IOM)

The Investigations Operations Manual (IOM) is the primary operational reference for FDA investigators and other field employees to perform investigational activities in support of the agency's public health mission. Although primarily used internally by FDA staff, it is available publicly so that regulated industry and other external stakeholders can better understand FDA operations.

*Individuals using assistive technology may not be able to fully access the information contained in these files.  Remediated files for Section 508 will be replaced shortly.  This note will be removed indicating fully compliant.

• IOM Investigations Operations Manual 2023 Complete [NEW!] 
• IOM Front Cover and First Page
• Foreword / Vision / Mission / Values
• Table of Contents
• Chapter S – Safety
• Chapter 1 - Administration 
• Chapter 1A - Notes, Records and Information 
• Chapter 2 - Regulatory 
• Chapter 3 - Federal and State Cooperation
• Chapter 4 - Sampling  [NEW!]
• Chapter 5 - Establishment Inspections 
• Chapter 6 - Imports 
• Chapter 7 - Recall Activities
• Chapter 8 - Investigations
• Appendix
• Index
• IOM Back Cover Page
• ORA Directory