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CLOSEOUT LETTER

PM Resources, Inc. dba Virbac Animal Health, Inc. Dec 15, 2016

PM Resources, Inc. dba Virbac Animal Health, Inc. - Close Out Letter 12/15/16


PM Resources, Inc. dba Virbac Animal Health, Inc.

 

  

Black HHS-Blue FDA Logo

 

 

 
Kansas City District Office
8050 Marshall Drive - Suite 205
Lenexa, Kansas 66214-1524
913-495-5100 

December 15, 2016

VIA UPS

Mr. Paul R. Hays, President and CEO
Virbac Corporation, North America
3200 Meacham Blvd.
Ft. Worth, TX 76137-4611

Dear Mr. Hays:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter [Ref: CMS # 450565] . Based on our evaluation, as well as information your firm provided during the meeting held at the District Office on November 3, 2016, 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/
Cheryl A. Bigham
KAN-DO District Director
 

Cc:

Steven Buchholz, Ph.D.
Vice President, Quality and Compliance
Virbac Animal Health, Inc.
13001 Saint Charles Rock Road
Bridgeton, MO 63044-2421