GMP Warning To Sandoz Questions Continued Lot Release; Will FDA Block It?
Executive SummaryFDA's warning letter to Sandoz over violations of good manufacturing practices suggests the agency is taking a stronger, but still measured, tone in its GMP oversight
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Upper management at Novartis and Sandoz are responsible for repeated cGMP violations at three Sandoz plants, FDA suggests. The agency’s warning letter, aimed at three sites in North Amercia, includes what may become new biolerplate instructions on drug shortages.