FDA to Meet Sanofi (France) Execs Over Violations at Vaccine Plants
Published: Jul 25, 2012
The FDA posted a July 12 warning letter to its website Tuesday involving two Sanofi Pasteur SA vaccine-manufacturing plants. The letter stemmed from plant inspections in Canada and in France that were conducted in March and April of this year. The FDA cited problems with mold at a plant in Toronto, Ontario, and cited a plant in Marcy-l'Etoile, France, because it didn't properly investigate failures of batches or components of certain vaccines. Much of the letter outlined problems involving TheraCys BCG Live, a product used to treat bladder cancer. Sanofi stopped production of that product in order to renovate the Toronto plant, according to the FDA, which has created a shortage of the product.