FDA Warns Sanofi Vaccine Unit on Manufacturing Violations at Two Facilities

FDA Warns Sanofi Vaccine Unit on Manufacturing Violations at Two Facilities

July 25th, 2012 // 11:50 am @

FDA stated this week that Sanofi SA’s (SNY, SAN.FR) vaccine unit violated agency manufacturing rules at two company facilities, and the company has temporarily stopped making a product used to treat bladder cancer to renovate one of the plants.

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.

A Sanofi Pasteur spokesman said non-BCG products, such as various childhood vaccines, are not impacted by FDA’s warning letter. One of the companies vaccines, Pentacel, is in short supply because of a manufacturing delay which started before the FDA’s March and April inspections. The vaccine is administered to children to protect them against several illnesses, including whooping cough and meningitis.

In a statement, the company said it was moving as quickly as possible to address issues identified during the FDA inspections.

“Sanofi Pasteur takes the observations outlined in the recent FDA warning letter seriously,” said Olivier Charmeil, Sanofi Pasteur’s chief executive. “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.”

Read more: http://www.foxbusiness.com/news/2012/07/24/fda-warns-sanofi-vaccine-unit-on-manufacturing-violations-at-two-facilities407024/#ixzz21dNuyJTR

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