FDA Warns Sanofi Vaccine Unit On Manufacturing Violations At Two Facilities

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.