Sanofi Pasteur Receives FDA Warning Letter - - BioPharm International

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Sanofi Pasteur Receives FDA Warning Letter


BioPharm Bulletin

On July 22, 2010, Sanofi Pasteur (Lyon, France) received a warning letter from the US Food and Drug Administration, citing deviations from current good manufacturing practices (cGMPs) in the manufacture of certain biological products and bulk drug substances, including Imovax Rabies, Imogam Rabies, Ipol, Act HIB, and Typhim Vi.

The letter describes deviations that occurred during FDA inspections that took place between March 15 and April 2, 2010 at the company’s manufacturing site at Marcy l’Etoile, France.

Key cGMP deviations that were noted were the failure to report batch discrepancies and biological product deviations, and the failure to inform the FDA of changes in production processes.

Additionally, the letter noted manufacturing deviations including the failure to follow standard operating procedures to prevent microbial contamination.

The letter stated that the company’s responses dated April 21, May 17, and June 11, which addressed the inspectional observances on the 483 Form issued after the inspection was completed, have been acknowledged.

The entire letter can be found on the FDA’s web site.

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