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.
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. It wasn't clear if any finished products were involved.
A Sanofi spokesperson didn't immediately return a message for comment on the FDA's letter.
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(END) Dow Jones Newswires
July 24, 2012 14:09 ET (18:09 GMT)
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