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  5. Backwoods Food Mfg Co Inc - 472863 - 04/19/2017
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CLOSEOUT LETTER

Backwoods Food Mfg Co Inc MARCS-CMS 472863 —

Recipient:
Backwoods Food Mfg Co Inc

United States

Issuing Office:

United States

 

   

Black HHS-Blue FDA Logo

 

 
 
Dallas District Office
4040 N. Central Expressway, Suite 300
Dallas, Texas 75204 

April 19, 2017

UPS Overnight

Danielle (NMI) Coursey, President, Co-Owner
Michael R. Coursey, Vice-President, Co-Owner
Backwoods Manufacturing, Inc.
591 Main Parkway
Tahlequah, Oklahoma 74464

Dear Ms. Coursey:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter (2015-DAL-WL-30, September 15, 2015). 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/
John W. Diehl
Acting Director, Compliance Branch
Dallas District Office

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