FDA Warns Sanofi Pasteur of “Significant Deficiencies”

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.

The post FDA Warns Sanofi Pasteur of “Significant Deficiencies” appeared first on Children's Health Defense.

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