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Mike Mitka

JAMA. 2007;298(22):2611.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

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.

Subcommittee Chairman Bart Stupak (D, Mich) noted that today more than 80% of active pharmaceutical ingredients that go into drugs come from outside the United States. "From the limited data we have gleaned from the agency, FDA's foreign drug inspection program has serious shortcomings," Stupak said.