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  5. Wellness Resources, Inc. - 537216 - 05/21/2019
  1. Warning Letters

CLOSEOUT LETTER

Wellness Resources, Inc. MARCS-CMS 537216 —

Product:
Food & Beverages
Recipient:
Recipient Name
Mary Guignon/Ryan J. Richards
Recipient Title
Owner and CEO/General Manager
Wellness Resources, Inc.

7155 Amundson Avenue
Edina, MN 55439-2020
United States

Issuing Office:
Center for Food Safety and Applied Nutrition

United States

(612) 334-4100

Dear Ms. Guignon and Mr. Richards:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS 537216 dated November 30, 2017. 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/
Boun M. Xiong
Compliance Officer, West Division 1 - CB
Office of Human and Animal Foods Operations

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