July 25, 2012 — After finding “significant objectionable conditions” at Sanofi vaccine manufacturing facilities in France and Canada, the U.S. Food and Drug Administration (FDA) is calling for a meeting with company executives and warning that some countries may face a tuberculosis vaccine shortage. The FDA sent a warning letter to Sanofi, citing 24 violations of good manufacturing practices at a Toronto, Canada facility, and an additional two violations at a Sanofi vaccine facility in Marcy I’Etoile, France.
The most serious issues were found at the Toronto facility, and a subsequent shutdown of the plant will lead to the shortage of the Bacillus Calmette-Guerin (BCG) tuberculosis vaccines. In the warning letter, the FDA wrote that “there have been no less than 58 documented non-conformances related to the isolation of mold within the BCG aseptic processing areas,” since August 2010.
The FDA is asking to meet with Sanofi chief executives, including Olivier Charmeil, the company’s head of vaccines. The health agency is ordering Sanofi to conduct a “comprehensive and global assessment of all its manufacturing operations and to ensure that all products conform to FDA requirements.” Charmeil has responded to the FDA and reporters by saying that he has full confidence in the vaccines, and the company is taking steps to address the FDA’s observations.
Sanofi has already been forced to recall some lots of the BCG vaccine due to sterility issues, in Australia, Canada, and New Zealand. Last month’s recall promoted the company to shut down vaccine production at the facility to improve manufacturing, sterility, and quality-control. This move is expected to cause a shortage of the BCG vaccine in some countries. It may also cause a shortage of other drugs made at the facility, but the company insists this will not happen.
In the warning letter, the FDA was concerned that the Toronto facility had not successfully passed a sterility test since 2000. Although Sanofi could not ensure that all lots of the BCG vaccine were safe, they only recalled specific lots last month. The FDA was also concerned that Sanofi’s quality-control team was not using a test that could detect mold in the vaccines.
There were also other sterility issues at the facilities. The Toronto facility had nesting birds in the air handling units and no separation between the washing area and the live vaccine handling area. Furthermore, at the French facility, quality-control investigators failed to determine why lots of Conjugated Haemophilus vaccine and typhoid vaccines failed quality assurance tests.
The FDA also noted that they will be informing federal regulators about the problems at Sanofi plants, which may influence contract awards when the U.S. purchases vaccines. Sanofi manufactures the most vaccines of any pharmaceutical company in the world.
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