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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enriching Gifts International, Inc. Closeout Letter 1/13/11

  

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 

January 13, 2011


Ronald K. Schneider, President
Enriching Gifts International, Inc.
915 South Lake Avenue
Miles City, Montana 59301


Dear Mr. Schneider:


The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter CFSAN-OC-10-27 dated September 9, 2010. 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/
Kathleen M. Lewis, J.D.
Team Leader
Labeling Compliance Team
Office of Compliance
Center for Food Safety
and Applied Nutrition