Resources for You
What does FDA inspect?
FDA inspects manufacturers or processors of FDA-regulated products to verify that they comply with relevant regulations. Those inspected include
- vaccine and drug manufacturers
- blood banks
- food processing facilities
- dairy farms
- animal feed processors
- compounding pharmacies
FDA also inspects
- facilities that conduct studies in people (clinical trials)
- laboratories that conduct studies in animals or microorganisms when these studies are used to apply for FDA approval of a medical product
- foreign manufacturing and processing sites for FDA-regulated products that are sold in the United States
- imported regulated products at the border
FDA conducts several types of inspections to help protect consumers from unsafe products:
- pre-approval inspection after a company submits an application to FDA to market a new product
- routine inspection of a regulated facility
- “for-cause” inspection to investigate a specific problem that has come to FDA’s attention
- How can I share my ideas and suggestions with FDA?
- Where should I go to find consumer information on www.FDA.gov?
- FDA's MedWatch Program: Voluntarily Reporting Problems to the FDA
- What does FDA regulate?
- What does FDA inspect?
- When and why was FDA formed?
- What is the difference between the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA regulations, and FDA guidance?
- What does FDA do?
- How is FDA organized?
- How many people are employed by FDA and in what areas do they work?
- What non-government websites does FDA recommend?
- What other government-supported websites does FDA recommend as reliable sources for health-related information?
- FDA Basics Webinar: FDA Office of Minority Health - Steps to Address Health Disparities
- How can the public request documents from FDA?
- Materials from Webinar on Inspection Process
- FDA Webinar on Foreign Inspections
- FDA MedWatch Webinar
- What is FDA Basics for Industry?
- FDA Basic Video: Kathleen Uhl on the Office of Women's Health (Video)
- Why can’t I import some drugs that are approved and sold in the United States?
- Is it legal for me to personally import drugs?
- What is a docket? How do I submit comments to a docket? How do I find comments submitted to a docket?
- How do I find the latest information on the Web site? How do I sign up for e-mails and alerts?
- How can I find out the status of my FOIA request?
- What is a recall?
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