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
FDA Approved Wrong China Firm
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)

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. (Read more Heparin stories.)

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