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
FDA makes available to the public certain frequently requested records of inspections in an electronic reading room. You would need to file a Freedom of Information request to obtain other records.