--Sanofi has temporarily stopped production of a BCG Live, a
bladder cancer product
--Company says other non-BCG vaccine products are not impacted
by the warning letter
(Updates with additional information on the warning letter and
adds company comment)
By Jennifer Corbett Dooren
WASHINGTON--The U.S. Food and Drug Administration Tuesday said
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."
Write to Jennifer Corbett Dooren at
jennifer.corbett@dowjones.com
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