WASHINGTON (Reuters) - Sanofi-Aventis failed to follow proper manufacturing procedures at a vaccine plant in France, U.S. regulators said in a letter released on Thursday.
Food and Drug Administration inspectors visited a plant operated by Sanofi Pasteur, the company’s vaccine unit, in Marcy l’Etoile, France, in March and April, the agency’s July 22 letter to the company said.
Inspectors found the company did not comply with federal manufacturing standards in the production of the Typhim Vi typhoid vaccine, the Imovax rabies vaccine and other products, the letter said.
“You failed to follow procedures designed to prevent microbial contamination,” the FDA said in one of its complaints about the plant.
The company said its products on the market were safe and effective.
“We either have already addressed the issues raised or are currently working diligently to address them,” Sanofi Pasteur Chief Executive Wayne Pisano said in a written statement.
William Aitchison, the company’s vice president of industrial operations, said he was confident the issues raised by the FDA could be corrected “in a timely way.” He said he did not expect vaccine supply to be disrupted.
The FDA posted the letter here
Reporting by Lisa Richwine, editing by Leslie Gevirtz and Matthew Lewis