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GAO criticizes FDA's inspections of foreign drug makers

Pharma Compliance Alert, November 7, 2007

The FDA can only identify inspection records for one-third of foreign pharmaceutical manufacturers, according to a Government Accountability Office (GAO) report.

According to the GAO report, the FDA oversees 3,249 foreign manufacturers, although they may not all export pharmaceuticals to the U.S. The FDA conducts an average of 241 inspections each year, which equates to roughly 7% of manufacturers.

The report also said the FDA does not have an exact number of the foreign manufacturers it oversees because different agency databases provide different estimates. Even when the FDA conducts inspections of foreign manufacturers, it must rely on the manufacturer for translators.

Click here to read more in the Wall Street Journal. Click here to read the GAO's report.

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