FDA inspects wrong Chinese plant

The linkurl:US Food and Drug Administration;http://www.the-scientist.com/article/display/36885/ admitted yesterday that it never inspected a Chinese facility supplying the active ingredient in heparin, a widely used blood thinner recently implicated in more than 350 adverse reactions and four deaths in US patients. The oversight resulted from a case of mistaken identity, according to a linkurl:story;http://www.washingtonpost.com/wp-dyn/content/article/2008/02/18/AR2008021802315.html?wpisrc=newsl

By | February 19, 2008

The linkurl:US Food and Drug Administration;http://www.the-scientist.com/article/display/36885/ admitted yesterday that it never inspected a Chinese facility supplying the active ingredient in heparin, a widely used blood thinner recently implicated in more than 350 adverse reactions and four deaths in US patients. The oversight resulted from a case of mistaken identity, according to a linkurl:story;http://www.washingtonpost.com/wp-dyn/content/article/2008/02/18/AR2008021802315.html?wpisrc=newsletter in today's (Feb. 19) __Washington Post__. The FDA apparently inspected a similarly named Chinese company that had nothing to do with producing heparin or the drug's active ingredient, a compound derived from an enzyme in pig intestines. "To date this is an isolated situation, but the wrong firm was put into the database," Joseph Famulare, deputy director for compliance at the FDA's center for drug evaluation and research, told __The Post__. The FDA said that it is dispatching inspectors to China to determine if recent problems with the drug are a result of the agency's mistake. Two US companies, Baxter and APP Pharmaceuticals, distribute heparin in this country, but the reported problems have only involved Baxter's product, which sources its active ingredient from the un-inspected plant west of Shanghai.

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