About FDA

Office of Global Regulatory Operations and Policy (GO)

FDA Globalization- Offices in China, Europe, Latin America, and IndiaThe Office of Global Regulatory Operations and Policy (also known as GO) comprises the Office of Regulatory Affairs and the Office of International Programs. The Deputy Commissioner for GO provides executive oversight, strategic leadership, and policy direction to FDA’s domestic and international product quality and safety efforts, including global collaboration, global data-sharing, development and harmonization of standards, field operations, compliance, and enforcement activities. A fuller explanation of FDA Globalization initiatives can be found on the International Programs - Globalization page

Last fiscal year, FDA oversaw more than 34 million shipments of FDA-regulated products, up from just 15 million shipments a decade ago. These products come from more than 150 nations, are handled by

A key aspect of globalization is the ever-increasing volume and complexity of imports coming to America’s shores. As the chart above documents, last fiscal year, FDA oversaw more than 34 million shipments of FDA-regulated products, up from just 15 million shipments a decade ago. These products come from more than 150 nations, are handled by 130,000 importers, and are manufactured, processed, or packaged at more than 300,000 foreign facilities.

GO Facts at a Glance (January 2017)

Total employees: 5,065

  • ORA: 4,899 employees
  • OIP: 154 employees including staff in Belgium, China, Chile, Costa Rica, India, Mexico, and the United Kingdom.

Work:

  • ORA conducted more than 16,100 domestic inspections in FY 2016. That amounts to roughly 1,340 inspections a month -- or about 44 inspections every day of the week.
  • Our labs analyzed approximately 35, 220 samples in FY 2016 – or more than 78 samples analyzed every single day of the week.
  • OCI, in Fiscal Year 2016, made 257 arrests, won 274 convictions, and secured nearly $375 million in fines, restitutions, asset seizures and forfeitures.
  • Overseas, our personnel conducted 3, 512 inspections in FY 2016, in locations ranging from China to Mexico to India.
  • GO has helped achieve the signing of more than 148 International Arrangements with more than 43 nations and multilateral partners regarding FDA's product quality and safety efforts.

 

Presentations and Testimony

FDA Voice Blogs

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