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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Merck & Co Inc. Close out Letter 9/13/10

  

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

Public Health Service
Food and Drug Administration
 Rockville MD 20857
 

SEP 13 2010

Mr. Raul E. Kohan
Executive Vice President
and President Animal Health,
Merck & Co., Inc.
2000 Galloping Hill Road
Kenilworth, NJ 07033


Dear Mr. Kohan:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter, March 12, 2010. 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/

Neal Bataller, ME, DVM
Director, Division of Compliance
Center for Veterinary Medicine