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CLOSEOUT LETTER

Four Elements Organic Herbals, LLC


Four Elements Organic Herbals, LLC

  

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

Public Health Service
Food and Drug Administration
 Minneapolis District Office
Central Region
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 758-7185
FAX: (612) 334-4142 

 

September 28, 2016
 
Jane H. Stevens
Owner
Four Elements Organic Herbals, LLC
P.O. Box 10
North Freedom, Wisconsin 53951
 
Dear Ms. Stevens:
 
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter MIN 15-08 dated March 4, 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/
Melissa I. Michurski
Compliance Officer
Minneapolis District