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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Sanofi Pasteur SA - Close Out Letter 4/25/14

  

Department of Health and Human Services' logoDepartment of Health and Human Services

Food and Drug Administration
 Center for Biologics Evaluation and
Research
1401 Rockville Pike
Rockville, MD 20852-1448

 

APR 25, 2014


UPS EXPRESS MAIL


Mr. Olivier Charmeil
Senior Vice President, Vaccines
Sanofi
World Wide Headquarters
54 rue La Boétie
Paris, France 75008


Dear Mr. Charmeil:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter [CBER-12-07 dated July 12, 2012]. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.


Sincerely,

/S/

Mary A. Malarkey
Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research

 

cc: Mr. Eric Berger
     Vice President, Industrial Operations
     Sanofi Pasteur Limited
     1755 Steeles Avenue West
     Toronto, Ontario
     Canada M2R 3T4

     Mr. Ron Hudcosky
     Associate Vice President
     Site Quality Operations
     Sanofi Pasteur Limited
     1755 Steeles Avenue West
     Toronto, Ontario
     Canada M2R 3T4

     Mr. Andre Dupont
     Vice President, Industrial Operations and Site Head
     Sanofi Pasteur S.A.
     Campus Merieux
     1541 Avenue Marcel Merieux
     Marcy l'Etoile, France 69280

     Mr. Joseph Quinn
     Senior Director and Authorized Official
     Regulatory Affairs, US
     Sanofi Pasteur, Inc.
     Discovery Drive
     Swiftwater, PA 18370

     Mr. Patrick O'Neil
     Senior Regulatory Affairs Business Liason
     Regulatory Affairs, North America
     Sanofi Pasteur, Inc.
     Discovery Drive
     Swiftwater, PA 18370