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FDA Foreign Offices Highlight Top Priority Activities

While most U.S. Food and Drug Administration (FDA) officials are based in the United States, some FDA employees work out-of-country in FDA’s foreign offices.  The United States Government Accountability Office’s (GAO) January 2015 Food Safety Report shows that FDA had ten employees in China, four in Europe, twelve in India, fourteen in Latin America, and ten in the Asia-Pacific region as of October 2014.

According to the GAO report, the Food Safety Modernization Act (FSMA) directed FDA’s foreign offices to “assist governments in those countries in ensuring the safety of food and other FDA regulated products” and to “conduct risk-based inspections of food and other products and support such inspections by foreign governments.”  FDA’s foreign offices partake in the following activities related to food safety:

  1. Build Relationships: FDA’s foreign offices engage, collaborate, and cooperate with foreign counterpart regulatory authorities, as well as other U.S. government agencies, in their respective countries.  Building relationships with these authorities allows timely exchange of information and encourages beneficial initiatives.
  2. Conduct Inspections and Investigations: FDA’s foreign offices conducted 140 inspections in fiscal year 2014, over ten times the amount conducted by foreign offices in 2010.
  3. Collect Samples: FDA’s foreign offices collect samples of FDA-regulated products destined for the U.S. and examine them for contaminants and other compliance issues.
  4. Manage Recalls: FDA’s foreign offices assist in engaging recalls of and tracking outbreaks related to FDA-regulated products in their respective areas.
  5. Gather and Assess Information: FDA’s foreign offices research the regulatory landscape of their respective areas and assess conditions and events that have the potential to affect the safety, quality, value, security, and availability of FDA-regulated products in that area.
  6. Educate: FDA’s foreign offices provide information to FDA-regulated industries in their respective areas regarding FDA standards and regulations.

The GAO asked FDA’s foreign offices to pick three activities that they felt were of top priority.  The offices chose multiple combinations of top priority activities, but the most common three activities chosen were gathering and assessing information, building relationships, and providing information to industry about FDA regulations.

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For assistance with FDA compliance, contact Registrar Corp at +1-757-224-0177 or receive Live Help from a Regulatory Advisor 24 hours a day at www.registrarcorp.com/LiveHelp.





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