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A Disgraceful/Dangerous Stat: FDA fails to inspect 2,390 Foreign Drug Factories

Image via WikipediaThe General Accountability Office has just released a report that the FDA miserably failed to follow through on suggestion to inspect manufacturing facilities outside the USA. The folks at the GAO writes that there is an  ?urgent need? to better protect public health.

Some stats from the GAO: In the FDA completed 424 foreign inspections. That more than the 324 inspections conducted in 2008. Also in 2009, 1,015 domestic inspections were completed. That is less than half of all USA run facilities. The GAO report says that equals one inspection every two and half years. Is that acceptable?

There were 3,765 facilities in the FDA databases, but 2,394 may never had been inspected. Is that acceptable?

Find the report here (PDF). Most damning conclusion? The GAO wrote: " Among other things, we determined that, because of inaccurate information in FDA?s databases, the agency did not know how many foreign drug establishments were subject to inspection."

 

Full post as published by A Georgia Lawyer on November 02, 2010 (boomark / email).