SUNDAY, JUNE 17, 2018

FDA cites Sanofi Pasteur vaccine manufacturing facility

The Food and Drug Administration recently cited several major problems it found during an inspection at a Sanofi Pasteur vaccine manufacturing facility in Marcy l’Etoile, France.

In a July 22 letter to the company, FDA inspectors said that Sanofi Pasteur did not comply with federal manufacturing standards with regards to the production of its Typhim Vi typhoid vaccine, the Imovax rabies vaccine and other products made at the plant.

The FDA also criticized Sanofi’s contamination prevention procedures. The letter referred to an inspection the FDA carried out between March 15 and April 2, 2010. During that time, the FDA's says it found the plant to lack operations and facilities that prevented “contamination or mix-ups.” The FDA did, however, note that the company appeared committed to implementing improvements.

Sanofi Pasteur quickly responded that its products were safe and effective, according to Reuters.

"We either have already addressed the issues raised or are currently working diligently to address them," Wayne Pisano, Sanofi Pasteur's CEO, wrote in a statement, Reuters reports.

William Aitchison, Sanofi Pasteur's vice president of industrial operations, told Reuters that he was certain that the FDA’s issues would be corrected in a timely fashion and that he did not expect the vaccine supply to be disrupted.