1. Pink Sheet

Sandoz GMP Warning Letter: Is The Problem Documentation, Or Leadership?

 
• By Martin Berman-Gorvine

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.

Sandoz International GMBH engaged in "multiple repeated violations" of current good manufacturing practices, while parent company Novartis AG "is not implementing global and sustainable corrective actions," according to an FDA warning letter

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• By Bridget Silverman

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