Office of Inspections and Investigations Also referred to as: OII
The U.S. Food and Drug Administration’s Office of Inspections and Investigations (OII) is the lead office for all FDA field inspection, investigation, import and emergency response related activities. OII partners with internal and external agency stakeholders to identify, collect, and evaluate evidence that empowers integrated regulatory decision making. OII inspects regulated products and manufacturers, and reviews imported products offered for entry into the United States. In pursuit of its mission, OII also works with its state, local, tribal, territorial and foreign counterparts.
OII Vision statement
Our global inspections and investigations ensure FDA regulated products are safe, trusted, and accessible.
OII Mission statement
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 does OII do?
- Import Program (Office of Import Operations)
- Bioresearch Monitoring (Office of Bioresearch Monitoring Inspectorate)
- Food Products Inspectorate
- Human Food (Office of Human Food Inspectorate)
- Animal Food (Office of Animal Food Inspectorate)
- Medical Device & Radiological Health (Office of Medical Device and Radiological Health Inspectorate)
OII Core Values
- Accountability - We take personal responsibility for meeting individual, team, and organizational commitments.
- Commitment to Public Health - We demonstrate our commitment to safeguarding the public health in our actions.
- Communication - We provide information that is accurate and clear, and in our interactions with others, we actively listen to understand other points of view.
- Integrity and Respect - We adhere to the highest ethical standards by consistently being honest and trustworthy in our actions.
- Quality - We set high standards of excellence for our work and take the necessary actions to continuously improve