The Food and Drug Administration needs to beef up its inspections and better manage its databases to strengthen its foreign drug inspection program, the Government Accountability Office concluded.
The GAO estimated that the FDA only inspects about 8% of foreign establishments in a given year to assess the manufacturing of drugs currently marketed in the United States. While it made progress in fiscal 2007 conducting more foreign inspections, it still inspected less than 11% of such establishments, the watchdog group stated.
The FDAs identification of serious deficiencies has led foreign establishments to take corrective actions, but subsequent inspections to determine continued compliance were not always timely, the GAO reported. In addition, the agencys databases contain inaccurate information on foreign establishments subject to inspection.
HHS agreed that the FDA should conduct more foreign inspections, but did not comment on GAOs other recommendations.
In a related development, HHS officials last week announced the department was preparing to open FDA offices in various parts of the world to better safeguard the nations supply of food and medicines. The goal is to send 43 full-time employees to offices in China, Europe, India and Latin America by next year. -- by Jennifer Lubell
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