FDA Warns Sanofi Pasteur of “Significant Deficiencies”

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In 2012, the Food and Drug Administration (FDA) conducted inspections of two Sanofi Pasteur vaccine production facilities. This 10-page letter from the FDA to Sanofi’s Senior Vice President of Vaccines, describes the significant objectionable conditions and deviations observed at each of the facilities.

These include (just to name a few):

• Failure to establish the accuracy, sensitivity, specificity, and reproducibility of test methods employed by your firm;
• Failure to assure an adequate system for cleaning and disinfecting aseptic processing areas and equipment;
• There have been no less than 58 documented non-conformances relating to the isolation of mold within the BCG aseptic processing areas since August 2010 and there is no documented evidence that corrective action in follow up to non-conformances relating to the isolation of mold within the BCG aseptic manufacturing areas includes cleaning with a sporicidal agent;
• You failed to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic processes.

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