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  5. Eagle Smoked Salmon, Inc. - 535576 - 12/05/2017
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CLOSEOUT LETTER

Eagle Smoked Salmon, Inc. MARCS-CMS 535576 —

Recipient:
Eagle Smoked Salmon, Inc.

United States

Issuing Office:

United States

 

   

Black HHS-Blue FDA Logo

 

P.O. Box 25087
Denver, CO 80225 
 
 

December 5, 2017

RE: Warning Letter Close-Out

Mr. George A. Osborne
Owner
Eagle Smoked Salmon, Inc.
452 Vicksburg, Lane
Gypsum, CO 81637

Dear Mr. Osborne:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter HAF4W(DEN)-17-15-WL, dated August 23, 2017. 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/

LaTonya M. Mitchell
Program Division Director
Office of Human and Animal Food Operations -
Division IV West

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