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  5. Down to Earth Solutions, LLC - 576999 - 06/17/2019
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CLOSEOUT LETTER

Down to Earth Solutions, LLC MARCS-CMS 576999 —

Product:
Dietary Supplements

Recipient:
Recipient Name
April Starks
Recipient Title
Owner
Down to Earth Solutions, LLC

78 Happy Hollow Rd
Clarksburg, WV 26301
United States

Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)

5001 Campus Drive
College Park, MD 20740
United States


Dear Ms. Starks:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter, CMS# 576999, dated April 10, 2019. 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/
Carrie Lawlor
Branch Chief
Dietary Supplement and Labeling Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition