The FDA admonished Sanofi Pasteur on more than two dozen counts for "objectionable" conditions in two vaccine plants in Canada and France, according to the agency's warning letter dated July 12 and made public July 24. A Toronto, Canada, plant did not meet good manufacturing practices on 24 counts, while a Marcy l'Etoile, France, plant flouted two such standards, according to the agency's letter.
Tests showed the sterility for TheraCys BCG-IT, used to treat bladder cancer, cannot be assured. This means there's no guarantee any BCG-IT drug manufactured after 2000--when the last BCG Sterility Test Method Validation was completed--is safe.
"As of today, this notification does not impact our ability to supply the market, except our BCG products manufactured in Toronto," Len Lavenda, a company spokesman, said in an email to FierceVaccines. TheraCys BCG-IT has not been available since mid-April.
In June, the company recalled four batches of BCG tuberculosis vaccine for that same lack of sterility assurance, according to Bloomberg. And the vaccine was recalled in Canada and New Zealand because of issues at the Toronto plant.
"Sanofi Pasteur takes the observations outlined in the recent FDA Warning Letter seriously," Olivier Charmeil, president and CEO of Sanofi Pasteur, said in an emailed statement to FierceVaccines. "We are working diligently with the FDA to implement a series of immediate and ongoing steps to address their concerns and further strengthen our global manufacturing operations and quality systems. I have full confidence in our products in the market."
- see the FDA warning letter
- read the Bloomberg piece
FDA ravages Sanofi vaccine sterility process in warning letter
Sanofi Pasteur plant idles for fixes after vax recall
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