STAT Plus: FDA cites Mylan for ‘repeated failures’ at manufacturing plants in India

For the second time in less than a year, the Food and Drug Administration has warned Mylan (MYL) over a failure to maintain standards at a plant that manufactures active pharmaceutical ingredients.

In a Sept. 1 warning letter, the agency admonished the big generic drug maker for not ensuring adequate cleaning procedures to prevent contamination and failing to assess the risks that impurities would find their way into solvents. The infractions occurred this past February at a plant in India.

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