FDA warning letter to Sanofi Pasteur plant in Canada

An FDA warning letter that lays out two dozen observations at a Sanofi Pasteur plant in Canada explains some of the mold and contamination problems that led the company to close some operations, a move that it says will lead to a shortage of BCG tuberculosis vaccine.

Sanofi Pasteur, the largest operation devoted to human vaccines in the world, in June recalled four batches of the tuberculosis vaccine BCG and suspended production at a plant in Canada after Australian regulators found problems with sterility. The result will be a shortage there, as well as perhaps in Canada. There were also worries that the halt in production could lead to a global shortage of the bladder cancer drug ImmuCyst, but spokesman Len Lavenda said that “As of today, this notification does not impact our ability to supply the market, except for our BCG products manufactured in Toronto.”

An FDA warning letter posted on the agency’s website lays out a particularly long list of observations, 24 at the plant in Toronto inspected in April, as well as a couple more found during a routine March inspection of a plant in Marcy l’Etoile, France. Among other problems at the Toronto plant, the FDA says, “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.