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Thread: FDA warns Novartis over vaccine sterility

  1. #1
    Administrator Islander's Avatar
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    Default FDA warns Novartis over vaccine sterility

    Tue Jan 29, 2008

    WASHINGTON (Reuters) - U.S. regulators warned Novartis AG that a German plant has produced contaminated vaccines, and it has failed to track down the source of the problems, a letter released on Tuesday said.
    The U.S. Food and Drug Administration found significant deviations from good manufacturing practices at the drugmaker's Marburg, Germany plant, which makes a rabies vaccine, and diphtheria and tetanus concentrates, according to January 24 letter posted on the FDA's Web site on Tuesday.
    The FDA letter cited multiple cases of contamination and non-sterility, and failure to test and track down the source of these cases.
    The agency gave the company 15 days to respond to the letter.
    A spokeswoman for Novartis was not available for comment.
    The FDA sends dozens of warning letters each year and most are resolved without further action. In rare cases, the agency can hold up approvals or seize products.
    (Reporting by Kim Dixon, editing by Richard Chang)

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  2. #2
    Veteran Member Reesacat's Avatar
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    Default Re: FDA warns Novartis over vaccine sterility

    OK, if the FDA is telling Novartis they are producing contaminated vaccines, how bad is it really? Much worse than just this, I would imagine.

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    Default Re: FDA warns Novartis over vaccine sterility

    "Failure to test and track down the source" of contamination. Why would they care when the vaccines themselves are harmful? Who's going to spot the difference?

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