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CLOSEOUT LETTER

JW Nutritional LLC Dallas


JW Nutritional LLC Dallas

 

  

Black HHS-Blue FDA Logo

 

Office of Human & Animal Food Operations West, Division 3
4040 N. Central Expressway, Suite 300
Dallas, Texas 75204
 

 
 

July 28, 2017

UPS Overnight

Jesse D. Windrix, President
JW Nutritional LLC
601 Century Parkway, Suite 300
Allen, Texas 75013

Dear Mr. Windrix:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter (2015-DAL-WL-15, March 25, 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/

Jeff R. Wooley
Acting Director, Compliance Branch
Office of Human & Animal Food, WD3