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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Sanofi-Aventis Deutschland GmbH - Close Out Letter 8/14/12

  

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

Public Health Service
Food and Drug Administration
 CENTER FOR DRUG EVALUATION AND RESEARCH
Office of Manufacturing and Product Quality
Division International Drug Quality
International Compliance Branch
10903 New Hampshire Avenue
Building #51, Room 4237
Silver Spring, MD 20993
TELEPHONE: (301) 796-4839
FAX: (301) 847-8742

August 14, 2012

Dr. Martin Siewert
Managing Director
Sanofi-Aventis Deutschland GmbH
lndustriepark Hochst, Gebaude/Building
K703, Frankfurt am Main, Germany 65926
Reference: FEI 3003195501

Dear Dr. Siewert:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 320-11-09 dated February 9, 2011. Based on our evaluation, it appears that you have addressed the violation(s) 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/

Rafael Arroyo
Division of International Drug Quality
Compliance Officer
Division of International Quality