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CLOSEOUT LETTER

Vietti Acquisitions, LLC 15/12/2016

Vietti Acquisitions, LLC - Close Out Letter 12/15/16


Vietti Acquisitions, LLC

 

  

Black HHS-Blue FDA Logo

 

 

 
New Orleans District
404 BNA Drive, Ste 500
Nashville, TN 37217 

December 15, 2016

Frank J. Baltz, Plant Manager
Vietti Acquisitions, LLC
P.O. Box 40464
Nashville, Tennessee 37204-0464

Dear Mr. Baltz:

The Food and Drug Administration has completed an evaluation of the corrective actions of Vietti Acquisitions, LLC, located at 636 Southgate Avenue, Nashville, TN, in response to our Warning Letter No. 2015-NOL-03 dated, November 3, 2014. Based on our evaluation, it appears 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.

If you have any questions, I may be reached at (615) 366-7811.

Sincerely,
/S/

Kimberly L. McMillan
Acting Director Compliance Branch
New Orleans District
 

Cc:

Frank Schmitt, General Manager of US Operations
Zwanenberg Food Group (USA) Inc
3640 Muddy Creek Road
Cincinnati, Ohio 45238
U.S.