Sanofi Warned By FDA Over Conditions In 2 Vaccine Plants

Law360, Washington (July 24, 2012, 6:12 PM EDT) -- Sanofi SA's vaccine unit was hit with a warning letter from the U.S. Food and Drug Administration, posted to the agency's website on Tuesday, for failing to meet good manufacturing practices and ensure the sterility of various vaccine products at two plants.

FDA's letter, dated July 12, contained a laundry list of infractions found at Sanofi Pasteur SA plants in Marcy l'Etoile, France and Toronto, Canada, in March and April of this year, including inadequate product sterility and environmental monitoring, unapproved manufacturing changes and a failure...
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