Sanofi Pasteur Receives FDA Warning Letter - - BioPharm International

ADVERTISEMENT

Sanofi Pasteur Receives FDA Warning Letter


BioPharm Bulletin

On July 22, 2010, Sanofi Pasteur (Lyon, France) received a warning letter from the US Food and Drug Administration, citing deviations from current good manufacturing practices (cGMPs) in the manufacture of certain biological products and bulk drug substances, including Imovax Rabies, Imogam Rabies, Ipol, Act HIB, and Typhim Vi.

The letter describes deviations that occurred during FDA inspections that took place between March 15 and April 2, 2010 at the company’s manufacturing site at Marcy l’Etoile, France.

Key cGMP deviations that were noted were the failure to report batch discrepancies and biological product deviations, and the failure to inform the FDA of changes in production processes.

Additionally, the letter noted manufacturing deviations including the failure to follow standard operating procedures to prevent microbial contamination.

The letter stated that the company’s responses dated April 21, May 17, and June 11, which addressed the inspectional observances on the 483 Form issued after the inspection was completed, have been acknowledged.

The entire letter can be found on the FDA’s web site.

blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

Compounding Pharmacy Issues Recall, But Challenges FDA Decision
July 22, 2014
AbbVie's Acquisition of Shire Could Save $8 Billion in Taxes
July 21, 2014
AstraZeneca Reveals Design for New Global R&D Center and Corporate Headquarters
July 18, 2014
AbbVie to Acquire Shire for $54.7 Billion
July 18, 2014
Particulate Matter Prompts Baxter's Recall of IV Solutions
July 17, 2014
Author Guidelines
Source: BioPharm Bulletin,
Click here