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River Hills Harvest dba Elderberrylife

River Hills Harvest dba Elderberrylife

United States

Issuing Office:

United States


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

 Food and Drug Administration
Southwest Region
Kansas City District
8050 Marshall Drive
Suite 205
Lenexa, Kansas 66214-1524

December 9, 2015


Mr. Terry D. Durham
River Hills Harvest dba Elderberrylife
19010 S. Mackie Ln.
Hartsburg, MO 65039-9112

Dear Mr. Durham:

The Food and Drug Administration has completed our evaluation of your corrective actions in response to our Warning Letter CMS # 420427 dated April 22, 2014. 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.



Cheryl A. Bigham
District Director
Kansas City District

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