Documents show FDA ignored warnings about flu-vaccine plant.

Publication: Knight Ridder Washington Bureau (Washington) (via Knight-Ridder/Tribune Business News)

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COPYRIGHT 2004 Knight Ridder Washington Bureau

Byline: Seth Borenstein

Nov. 18--WASHINGTON -- The Food and Drug Administration failed to heed repeated warnings of contamination at Chiron's now-shuttered British flu-vaccine plant and the urging of U.S. inspectors for a crackdown, documents released Wednesday show.

Instead of forcing the company to clean up its Liverpool manufacturing plant as inspectors had recommended, the FDA left it up to Chiron to fix the problem voluntarily.

When British health authorities intervened, they found widespread contamination with a dangerous bacteria at the plant. Last month, the British government yanked the license for the plant, which produced about half the American flu-shot supply.

That created a flu vaccine shortage in the United States.

More than 1,000 pages of FDA, Chiron and British health-authority documents, released at a congressional hearing, show that the agency failed to act after...

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