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FDA Issues Multinational Warning Letter | BioQuality.biz

14 Page Letter for Sanofi-Pasteur in Canada and France

From the June/July Issue of BioQuality

Sanofi-Pasteur in Canada and France received a 14 page joint warning letter from the USFDA last week. Twenty-four items were specifically written for the facility in Toronto, Canada and two items for the Marcy l’Etoile, France facility. Additionally the letter reviewed 20 inadequate 483 responses from the firms. To read the entire story and see our bullet point summary and analysis of this important WL, become a BioQuality subscriber–all current and back issues of BQ are available for subscribers to view or download. Plus, there are bullet point summaries of 483s from FDA inspections of biopharma and biologics firms (from 2010 – present, with more back years to come soon).

To see the Warning Letter: Click Here

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