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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

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Sanofi - Aaventis U.S. LLC - Close Out Letter 7/5/11

  

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

Public Health Service
Food and Drug Administration
 

Waterview Corporate Center
10 Waterview Blvd., 3rd Floor
Parsippany, NJ 07054

Telephone (973) 331-4900

July 5, 2011


Barbara Rullo, MD
Vice President, Drug Safety, US Medical Affairs
Sanofi-Aventis US LLC
55 Corporate Drive
Bridgewater, New Jersey 08807


Dear Dr. Rullo:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 11-NWJ-06, dated January 28, 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 expect 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/


Nancy Rolli
Director, Compliance Branch
New Jersey District Office

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