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FDA Warning Letter Cites Mold and Contamination at Tuberculosis Vaccine Plant

Filed July 26th, 2012 Laurie

Mold and contamination problems at a Sanofi Pasteur plant in Canada are detailed in a Food and Drug Administration warning letter, pointing out over two dozen observations that forced the company to close some operations. The move could lead to a shortage of BCG tuberculosis vaccine.

Sanofi Pasteur recalled four batches of the vaccine in June and halted production at a plant in Canada after Australian regulators found problems with the sterility of the products. Now both countries are facing a shortage of the vaccine. There is also concern that shuttering the plant might lead to a global shortage of the bladder cancer drug ImmuCyst.

The letter, posted Tuesday to the FDA’s website, lays out 24 observations from the Canadian plant, and a couple more found during a routine March inspection of a plant in Marcy l’Etoile, France. The letter states “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.

The letter also stated that because of testing issues, the company cannot be certain that all of the BCG vaccine lots manufactured in one building since the last successful sterility test in 2000 are safe. The agency questions the company’s ability to detect mold in the product.

The FDA has ordered Sanofi to do a “comprehensive and global assessment of all of its manufacturing operations to ensure that all products conform to FDA requirements.”

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