FDA warns Novartis on Austrian generic manufacturing plant cGMP failures
The US Food and Drug Administration has written to Joseph Jimenez, chief executive of Swiss drug major Novartis (NOVN: VX), relating to its investigation of the pharmaceutical manufacturing plant at Ebewe Pharma’s Unterach am Attersee, Austria, production facility, which identified significant violations of current good manufacturing practice (cGMP) regulations for finished pharmaceuticals. Ebewe was acquired by Novartis’ generics subsidiary Sandoz in 2009.
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