Office of Inspections and Investigations Also referred to as: OII
Who We Are
The FDA’s Office of Inspections and Investigations (OII) leads all FDA field inspection, investigation, import, emergency response and law enforcement activities to protect America’s public health and safety. In this unique position as FDA’s sole regulatory field operations organization, the real-time evidence and insights observed and collected by OII are essential in empowering the Agency to make unbiased, fact-based regulatory decisions that protect public health.
For more than 100 years, OII has served as the FDA’s premiere field force working to protect the safety of America’s foods, drugs, and medical products.
Vision:
Our global inspections and investigations ensure FDA-regulated products are safe, trusted, and accessible.
Mission:
We conduct rigorous, transparent, and science-based inspections and investigations, providing real-time evidence and insight essential in empowering fact-based regulatory decisions to protect public health.
What We Do
OII is at U.S. borders and International Mail Facilities with a footprint across the United States, including Guam and Puerto Rico, and in more than 90 countries, scrutinizing the products U.S. consumers rely upon and ensuring that their production, manufacturing, and importation comply with federal law.
Our Work
Inspections identify hazards before they escalate into public health crises. By examining production facilities, imported products, and processes, OII can pinpoint areas of concern and enforce corrective actions to mitigate risks.
OII conducts ~30,000 inspections per year, both domestically and internationally, to ensure compliance with FDA regulations in collaboration with our regulatory partners.
Investigations are used to determine and document facts concerning consumer complaints, health fraud, product tampering, and recall compliance.
Import operations prevents violative products from entering the domestic market, ensuring that all products regulated by the Food and Drug Administration, whether imported from abroad or produced domestically, meet the same requirements.
Emergency Response provides immediate response, ranging from threats to the supply chain, contamination of over-the-counter medicines, to ensuring companies can safely manufacture food, drugs, and medical products after a domestic or international natural disaster.
To learn more about what each of these functions do, view the Medical Product Inspectorate, Food Product Inspectorate, Imports, Criminal Investigations, and Emergency Response Fact Sheets.
- Delivering Rapid Response on the Frontlines of Public Health (Emergency Response)
- Safeguarding American Food Supply and Preventing Foodborne Illness (Food Product Inspectorate)
- Ensuring the Safety and Quality of Medical Products (Medical Product Inspectorate)
- Investigating Crimes that Endanger Public Health (Criminal Investigations)
- Safeguarding Product Entry into the U.S. (Import Program)
Who We Partner With
In pursuit of its mission, OII works with its state, local, tribal, territorial, and foreign counterparts to keep the U.S. food and drug supply safe for consumers. We train and educate our collaborators to support scientific and regulatory expertise.
Through mutual recognition agreements between the FDA and foreign regulatory authorities, drug investigators rely on information from inspections conducted within one another’s borders.
OII also works with trusted partners on domestic mutual reliance, which enables the FDA and states with comparable regulatory public health systems to rely on, coordinate with, and leverage one another’s work, data, and actions to meet the public health goal of a safe national food supply.