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FDA Cites Violations at Three Novartis AG (NVS) Plants


12/7/2011 8:18:44 AM

Drug regulators cited Novartis AG for "significant violations" of manufacturing regulations at its three generic drug plants in the United States and Canada, several of which were repeat offenses. U.S. Food and Drug Administration investigators found a lack of proper procedures to ensure the drugs' sterility and correct composition. They also found inadequate cleaning at one of the plants, FDA said in a warning letter posted on Tuesday. FDA inspected plants of Novartis' Sandoz unit in Broomfield, Colorado; Wilson, North Carolina; and Quebec earlier this summer.

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