How does FDA train and guide its Inspectors?

The U.S. Food and Drug Administration FDA has updated its 2025 Investigations Operations Manual (IOM). The FDA's It is the primary field manual for investigators at the FDA and provides detailed procedures, policies, and guidance for FDA field staff when conducting regulatory inspections and investigations, including those in the pharmaceutical, biotech, and medical device industries.

Besides inspection procedures (e.g. how to prepare, conduct, and document inspections, interviewing techniques), it also describes evidence collection, sample collection and handling follow-up actions.

But also pharmaceutical industry can benefit from the various chapters. Understanding the IOM helps companies anticipate FDA expectations and better prepare for inspections-especially regarding facility readiness, documentation, and staff conduct. Before an inspection, companies can use the IOM to benchmark their processes and systems against FDA investigative procedures, proactively identifying compliance gaps.

During an inspection it can help to improve communication During Inspections. Knowing how FDA investigators are instructed to communicate and document findings helps companies engage more effectively and avoid missteps during inspections.

The 2025 edition of the FDA's Investigations Operations Manual (IOM) introduces a new Chapter 9 - Public Health Collaboration, which outlines the FDA's strategies for partnering with various governmental and non-governmental entities to enhance public health protection.