Inspectors found “significant objectionable conditions” at Sanofi vaccine plants in Canada and France, the U.S. Food and Drug Administration said.
Regulators summoned Olivier Charmeil, the Paris-based drugmaker’s head of vaccines, and other senior executives for a meeting to discuss the issues, the agency said in a July 12 letter to Charmeil made public today. The Sanofi Pasteur vaccines unit is taking steps to address the FDA’s comments and has confidence in products made at the facilities, the company said in an e-mailed statement.
The FDA cited 24 instances in which a Toronto plant failed to meet good manufacturing practices, including failure to follow appropriate procedures to prevent drug contamination. Two violations were found at a factory in Marcy l’Etoile, France, according to the letter.
Sanofi voluntarily recalled four batches of Bacillus Calmette-Guerin tuberculosis vaccine because the product’s sterility can’t be assured, Australia’s drugs regulator said last month. The vaccine was also recalled in Canada and New Zealand, while manufacturing at a plant in Toronto was suspended for renovation and to improve environmental quality management within the building, Patricia Waghorn, Sanofi’s head of communications for Australia and New Zealand, said at the time.
“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.”