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Sanofi Pasteur and Cangene get FDA "untitled" letters for GMP deviations

This article was originally published in Scrip

Executive Summary

The US FDA has issued an "untitled" letter to Sanofi Pasteur after uncovering "documented significant deviations" relating to the firm's good manufacturing practice at its Marcy l'Etoile, France, vaccine manufacturing facility. The problems were described as needing corrective action but not meeting the threshold of regulatory significance for a full-blown warning letter. Similarly, a letter was provided to Cangene for one of its plants. Both letters constitute merely an initial correspondence citing concerns.



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