Tag Archives: Warning Letter

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 […]
Posted in Europe, FDA, Global, Guest Blog, Manufacturing, Regulatory | Also tagged , , , | Leave a comment

Is FDA Watching YouTube?

Two weeks ago, Shire received a warning letter for posting a sponsored testimonial on YouTube without including risk information. Shire was very open when I called them up and admitted that the video was posted by accident and immediately removed when it was brought to the company’s attention. While I’m not 100 percent positive, it […]
Posted in E-Media, Marketing, Regulatory | Also tagged , , , , , , , | 6 Comments
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