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Post by jmo on Jan 30, 2008 13:55:04 GMT -5
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. more
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