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GAO Report Finds FDA's Foreign Drug Inspection Program Needs Significant Improvement

News release: “A Government Accountability Office (GAO) report released today found better data management and more inspections are needed to strengthen the Food and Drug Administration’s (FDA) foreign drug inspection program. The report was requested by Reps. John D. Dingell (D-MI) and Joe Barton (R-TX), Chairman and Ranking Member of the Committee on Energy and Commerce, Bart Stupak (D-MI) and John Shimkus (R-IL), Chairman and Ranking Member of its Subcommittee on Oversight and Investigations, Senator Charles Grassley (R-IA), Ranking Member of the U.S. Senate Committee on Finance, and Rep. Ed Whitfield (R-KY), Ranking Member of the Committee on Energy and Commerce’s Subcommittee on Commerce, Trade and Consumer Protection.

The lawmakers asked GAO to assess (1) the extent to which FDA has accurate data on the number of foreign establishments subject to inspection, (2) the frequency of foreign inspections, and (3) oversight by FDA to ensure that foreign establishments correct serious problems identified during inspections. GAO analyzed information from FDA databases, reviewed inspection reports which identified serious deficiencies, and interviewed FDA officials.”

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