The world’s largest drug manufacturer is in big trouble with the FDA due to multiple problems at one vaccine plant, and a few problems at another.
The FDA reprimanded Sanofi Pasteur on more than two dozen counts for “objectionable” conditions in two vaccine plants in Canada and France, according to a warning letter dated July 12 and made public July 24, 2012. A Toronto, Canada, plant did not meet good manufacturing practices on 24 counts, while a Marcy l’Etoile, France, plant had two such issues, according to the agency’s letter.
“The deficiencies described in the Form FDA 483 issued at the close of each inspection… are an indication of your quality control units not fulfilling their responsibility to assure the identity, strength, quality, and purity of your licensed biological drug products and intermediates,” the FDA stated.
With the news, some are concerned with product quality, as well as product availability.
“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. 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,” Charmeil said in the e- mailed statement. “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.”
The FDA isn’t so sure. According to the warning letter tests showed the sterility for TheraCys BCG-IT, used to treat bladder cancer, cannot be assured. It says that because of testing issues, the company can’t be sure that all lots of the BCG vaccine manufactured in one building since the last successful sterility test in 2000 are safe.
According to the FDA, the Toronto inspection revealed that, “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 warning letter says there are questions whether the test the company has used is capable of detecting mold in the product.
In addition, FDA investigators had issues with vial handling in the aseptic processing area in the filling and packaging building, the fact that employees were allowed unchallenged from the live vaccine area into the washing and sterilizing area, had questions about its disinfection practices, and observed on April 18 that there were “nesting birds” in the air handling units.
In France, problems included not thoroughly investigating what caused some lots of Conjugated Haemophilus Vaccine and typhoid vaccines to test out of specifications.
The agency has ordered the company to do a “comprehensive and global assessment of all of its manufacturing operations to ensure that all products conform to FDA requirements” and suggested a meeting with company executives to discuss their responses and plans. The agency also said that all warning letters about biological products “are passed along to federal agencies so that they may take this information into account when considering the award of contracts.”