Another Novartis AG Manufacturing Facility Gets an FDA Lashing

Published: Jun 06, 2013

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Novartis employees may take ceo Joe Jimenez seriously when he insists that quality matters (remember this?), but the FDA is not taking him at his word. Once again, the agency has issued the drugmaker a warning letter and, this time, the subject is the Ebewe Pharma generic injectables business in Austria, which last year experienced production problems that led to shortages and at least one product ban. The warning letter is only the latest sent by the FDA to Novartis concerning manufacturing issues at different facilities. Over the past two years, the agency has found infractions at a Sandoz plant in Canada and two others in Colorado and North Carolina in the US (see here and here), and the drugmaker also failed repeated inspections at a Nebraska plant that has since scaled back production to a select number of products.

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