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FDA Approved Wrong China Firm

Hundreds ill, 4 dead after using heparin from factory never inspected

By Peter Fearon,  Newser Staff

Posted Feb 19, 2008 6:26 AM CST
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(Newser) – The Chinese facility that supplied the active ingredient of the blood-thinner heparin, linked to hundreds of adverse reactions and four US deaths, was never inspected by the FDA because the agency confused it with another plant of the same name, the Washington Post reports. The company was given approval based on an earlier FDA inspection of the other factory. "The wrong firm was put into the database," said the FDA's deputy director.

An FDA team is headed to China now to inspect the right plant to determine what may have caused serious problems with the blood thinner. One of heparin's two manufacturers stopped selling it earlier this month, and the FDA yesterday advised physicians to prescribe alternatives. The FDA's commissioner has recommended inspectors be permanently based in China to address mounting concerns about the safety of Chinese products.

A syringe of the blood thinner Heparin. FDA inspectors examined the wrong Chinese plant believing they were inspecting one that processed the active ingredient of the widely used drug.
A syringe of the blood thinner Heparin. FDA inspectors examined the wrong Chinese plant believing they were inspecting one that processed the active ingredient of the widely used drug.   ((c) passamanerie)
Food and Drug Administration Commissioner Andrew von Eschenbach testifies on Capitol Hill. FDA inspectors examined the wrong plantin China believing it processed Heparin.(AP Photo/Susan Walsh)
Food and Drug Administration Commissioner Andrew von Eschenbach testifies on Capitol Hill. FDA inspectors examined the wrong plantin China believing it processed Heparin.(AP Photo/Susan Walsh)   (Associated Press)
Vials of Heparin made in China
Vials of Heparin made in China
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Made in China

Mix-up behind FDA's failure to inspect China plant
US News & World Report

Mix-up blamed for FDA failure on China heparin plant
Bloomberg

World • Health • Money

 
China • FDA • blood pressure • Government Accountability Office • inspection • House Energy and Commerce Committee • John Dingell • pharmaceutical industry • Heparin • Baxter International • blood thinner • Changzhou • Joseph Famulare • drug manufacturer • Andrew von Eschenbach

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