Summary

US GAO Report on FDA’s Drug Inspection Program

Author:

Monitoring and Reporting Working Group

In 2008 and 2010, GAO examined FDA’s foreign drug inspection program and recommended it conduct more foreign inspections.  In another 2010 report, GAO recommended the agency develop strategic and workforce plans for its foreign offices.  GAO was asked to update its work with a focus on FDA’s oversight of foreign drug establishments.

 This study from December 2016 examines:

  • enhancements FDA has made to its foreign drug inspection program; and
  • FDA’s assessment of its foreign offices, and the challenges they face in ensuring drug safety.

GAO analyzed FDA’s inspection data from fiscal year 2007 through June 30, 2016; reviewed agency planning documents; and interviewed FDA officials, including former foreign office employees.

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