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Capitol Health Call
December 12, 2007

FDA Oversight Questioned

JAMA. 2007;298(22):2611. doi:10.1001/jama.298.22.2611-d

The Food and Drug Administration (FDA) is not adequately inspecting foreign manufacturing plants where medicine and ingredients for pharmaceuticals are made for importation to the United States, raising safety concerns, Congressional investigators said.

These investigators said data suggest that the FDA inspects about 7% of foreign establishments in a given year, meaning it would take more than 13 years to inspect each plant once (US facilities are inspected every 2 years). These findings were given in a report by the Government Accountability Office presented November 1 at a hearing of the House Committee on Energy and Commerce's Subcommittee on Oversight and Investigations.