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  1. FDA Basics

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.


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