GMPTips - Congressional report condemns FDA - Nov 18, 2008

The U.S. Government Accountability Office (GAO), the investigative arm of Congress, recently issued a report condemning FDA’s ability to monitor foreign drug manufacturers. The GAO said the FDA has faulty records on the facilities it oversees because it doesn't require companies to update information such as corporate names and addresses annually. "FDA does not know the number of establishments subject to inspection," the report says. Currently, domestic companies are inspected about every 2.7 years, but the rate for foreign inspections is roughly once every 13 years.

The report "confirms that the system deployed by FDA to police (foreign) facilities and keep Americans safe from poorly manufactured drugs is understaffed, overwhelmed and completely inadequate," said Rep. Bart Stupak, D-Mich.

Read two news accounts and the GAO report. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

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