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Capitol Health Call
December 10, 2008

Foreign Inspections

JAMA. 2008;300(22):2599. doi:10.1001/jama.2008.749

Inspection by the Food and Drug Administration (FDA) of foreign manufacturing facilities that produce pharmaceuticals to be marketed in the United States is woefully lacking, according to a report released on October 22 by the Government Accountability Office (GAO) (http://www.gao.gov/new.items/d08970.pdf).

The GAO report said FDA databases contain inaccurate information on foreign facilities subject to inspection and may not contain all the plants involved in producing ingredients and actual drugs for sale in the United States. It also noted that the agency generally inspects foreign plants only if they are named in an application for new drug approval. At the recent rate of inspection of foreign drug-producing plants (1479 facilities from fiscal years 2002 through 2007), it would take about 13 years before such facilities would be inspected again, the report said. In contrast, the FDA estimates it inspects domestic facilities once every 2.7 years.