About FDA

Office of Global Regulatory Operations and Policy

FDA Globalization China, India, Europe, and Latin America

The 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


To receive periodic updates on GO activities, please send an email to Jeff.Nelligan@fda.hhs.gov with GO Listserv in the subject box.

GO Facts at a Glance (April 1, 2015)

Total employees: 4,450

  • ORA: 4,300 employees -- includes approximately 1,700 investigators, 650 lab analysts, and 220 OCI Special Agents in locations throughout the U.S.
  • OIP: 154 employees including staff in Belgium, China, Chile, Costa Rica, India, Mexico, and the United Kingdom.

Work:

  • ORA conducted more than 15,400 domestic inspections in FY 2014. That amounts to roughly 1,280 inspections a month -- or 42 inspections every day of the week.
  • Our labs analyzed approximately 37,000 samples in FY 2014 – or more than 74 samples analyzed every day of the week.
  • OCI, in Fiscal Year 2014, opened 398 cases, made 332 arrests, won 306 convictions, and secured $2.1 billion in fines and restitutions.
  • Overseas, our personnel conducted 3,067 inspections in FY 2014, in locations ranging from China to Mexico to India.
  • Along with the Office of Foods and Veterinary Medicine, GO is working on an operational plan to implement FSMA, the Food Safety and Modernization Act.
  • GO has helped achieve the signing of more than 135 International Arrangements with more than 26 nations regarding FDA's product quality and safety efforts. 
  • GO contracts with its state partners in the performance, in FY 2014, of approximately 22,000 food, feed, drug and device inspections annually in programs that reach all fifty states.
  • GO professionals oversee more than 32 million lines of FDA-regulated products at more than 380 ports of entry and international mail facilities.

 

Presentations and Testimony

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Page Last Updated: 06/10/2015
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