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  1. Inspections, Compliance, Enforcement, and Criminal Investigations

Inspection Basics

FDA Inspections

The FDA takes its responsibility seriously to ensure the foods we eat are safe and the medical products we use and rely on meet our rigorous standards for quality, safety and effectiveness. The agency uses risk-based approaches to identify foreign and domestic facilities for inspection.  

An inspection is a careful, critical, official onsite examination of a facility to determine its compliance with federal law. Although inspections are critical to FDA oversight, they are a snapshot in time, which is why inspections are one part of a comprehensive approach to oversee the safety and quality of FDA-regulated products.

Products manufactured outside the U.S must meet the same standards as products made in the U.S. The agency remains vigilant in addressing potential issues in the global supply chain, so Americans are confidence in the safety and quality of their product no matter where it is manufactured. 

What the FDA inspects

The FDA inspects manufacturers of FDA-regulated products to verify that they comply with relevant regulations, including: 

  • vaccine and drug manufacturers
  • blood banks
  • food processing facilities
  • dairy and produce farms
  • animal feed processors
  • outsourcing facilities and compounding pharmacies
  • tobacco manufacturers

The 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 U.S.
  • imported regulated products at the border

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