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  5. Merck Animal Health - 10/12/2016
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CLOSEOUT LETTER

Merck Animal Health


Recipient:
Merck Animal Health

United States

Issuing Office:

United States


 

  

Black HHS-Blue FDA Logo

 

 

 
New Jersey District Office
10 Waterview Blvd. 3rd Floor
Parsippany, New Jersey 07054 

October 12, 2016
 

VIA UNITED PARCEL SERVICE

Mr. Richard R. Deluca Jr.
Executive Vice President and President
lntervet Inc. (d/b/a Merck Animal Health)
2 Giralda Farms
Madison, NJ 07940

Dear Mr. Deluca:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter, dated January 28, 2016. 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/
Stephanie Durso
Acting Director Compliance Branch
New Jersey District Office
 

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