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  5. iSatori, Inc. - Close Out Letter 4/19/15
  1. Compliance Actions and Activities

CLOSEOUT LETTER

iSatori, Inc. 19/04/2015

iSatori, Inc. - Close Out Letter 4/19/15


iSatori, Inc.

  

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
 Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740

 

Stephen Adele
CEO
iSatori, Inc. (aka iSatori Global Technologies, LLC)
15000 W. 6th Avenue, Suite 202
Golden, Colorado 80401-5047


Dear Mr. Adele:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter dated April 25, 2012. Based on our review, it appears that you have addressed the violations contained in this Warning Letter. Future FDA assessments 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 (the 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 review of your web sites or through other means.


Sincerely.

/S/

Kathleen M. Lewis, J.D.
Team Leader
Labeling and Dietary Supplement
              Compliance Team
Center for Food Safety
              and Applied Nutrition


Cc:
Michael D. Wilemon
CFO