GMP Deviations at Sanofi Plant Lead to Untitled Letter

Sanofi Pasteur SA has received an FDA untitled letter after failure to report biological product deviations, control microbial contamination and establish control systems to prevent contamination or product mix-ups.

The Marcy l’Etoile, France, facility also failed to thoroughly investigate recurring out-of-specification pyrogen results for Typhim Vi, a typhoid vaccine, according to the July 22 letter the FDA recently posted online. The investigation identified a probable root cause but failed to evaluate certain incoming raw materials to rule them out as a potential root cause.

The company has already addressed many of the issues raised and is working to address others, Wayne Pisano, president and CEO of Sanofi Pasteur, said. The company has action plans in place, and the issues should not disrupt its supply of vaccines, William Aitchison, vice president of industrial operations, added.
Drug GMP Report