FDA inspects wrong Chinese plant

The linkurl:US Food and Drug Administration;https://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;https://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.

Popular Now

  1. That Other CRISPR Patent Dispute
    Daily News That Other CRISPR Patent Dispute

    The Broad Institute and Rockefeller University disagree over which scientists should be named as inventors on certain patents involving the gene-editing technology.

  2. How Gaining and Losing Weight Affects the Body
    Daily News How Gaining and Losing Weight Affects the Body

    Millions of measurements from 23 people who consumed extra calories every day for a month reveal changes in proteins, metabolites, and gut microbiota that accompany shifts in body mass.

  3. DOE-Sponsored Oak Ridge National Laboratory to Cut 100 More Jobs
  4. Neurons Use Virus-Like Proteins to Transmit Information
AAAS