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CLOSEOUT LETTER

Journey Health USA, LLC


Journey Health USA, LLC

 

  

Black HHS-Blue FDA Logo

 

5001 Campus Drive
College Park, MD 20740 

 
 

September 1, 2017

Anthony Shaw, CEO
Journey Health USA, LLC
4044 Weletka Drive, Suite B
Austin, TX 78734
tonyshaw78734@gmail.com

Dear Mr. Shaw:

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #486996, issued March 7, 2016. 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/
Latasha A. Robinson, M.S.
Branch Chief
Dietary Supplement Labeling Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition