Tag Archives: cGMP

FDA Warning to GSK Biologicals

FDA issued a warning letter to GlaxoSmithKline Biologicals (GSK), North America on June 12, 2014 for deviations from cCGMP requirements found during an inspection from Mar. 31 to Apr. 9, 2014 of its influenza vaccine manufacturing facility in Quebec. GSK is making progress in addressing FDA’s concerns and is working to meet supply commitments, the […]
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FDA Issues Warning Letter to Novartis's Austrian Plant

FDA has issued a Warning Letter to Novartis for cGMP violations at its manufacturing facility for finished pharmaceuticals in Unterach, Austria. The site became part of Sandoz and Novartis through the acquisition of EBEWE Pharma in 2009. The Warning Letter was issued based on an inspection of the facility from Oct. 15–23, 2012 at which […]
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