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FDA warns Novartis about contaminated German plant

1/31/2008

WASHINGTON The Food and Drug Administration has warned Novartis that its German plant has produced contaminated vaccines, and it has failed to track down the source of the problems, according to a letter released by the agency.

The FDA found major deviations from what it considers good manufacturing practices at the plant, which makes a rabies vaccine and diphtheria and tetanus bacteria concentrates. The FDA sent the letter to the company on Jan. 24 and has given it 15 days to respond.

Novartis was not available to comment.

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