GAO: Too Early to Determine Whether FDA Overseas Inspections Are Effective

The overseas inspection offices opened in 2008 and 2009 by the Food and Drug Administration are operating well, but it is too early to determine their effect, if any, on the safety of imported products, says a new report by the Government Accountability Office.

The overseas inspection offices opened in 2008 and 2009 by the Food and Drug Administration are operating well, but it is too early to determine their effect, if any, on the safety of imported products, says a new report by the Government Accountability Office.

The report also stressed the need for more long-term planning. FDA is in the process of long-term strategic planning for the overseas offices but has not developed a long-term workforce plan, according to the report.

FDA established overseas offices in late 2008 and early 2009 comprising 42 total staff members covering particular countries or regions — China, Europe, India, Latin America, and the Middle East.

The overseas offices have been establishing relationships with foreign regulators, industry, and U.S. agencies overseas, the report noted.

The offices engage with foreign stakeholders to develop information that FDA can use to make sounder decisions about products manufactured overseas.

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