FDA Chastises Novartis Unit Over Safety Issues

Law360 (January 30, 2008, 12:00 AM EST) -- The U.S. Food and Drug Administration has sent a warning letter to the vaccine-making subsidiary of Novartis AG over a number of “significant deviations” from quality-control practices at one of the Swiss drugmaker's facilities in Germany.

The letter, sent Jan. 24 to Novartis Vaccines and Diagnostics Chief Executive Joerg Reinhardt and made public on the FDA's Web site on Tuesday, said that during an inspection of the Marburg, Germany-based plant last September, investigators had “documented a number of significant deviations from current good manufacturing practices" in...
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