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  5. Earthworks Health - 560772 - 02/04/2020
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CLOSEOUT LETTER

Earthworks Health MARCS-CMS 560772 —

Delivery Method:
VIA UPS
Product:
Animal & Veterinary
Dietary Supplements

Recipient:
Recipient Name
Larry D. Smith
Recipient Title
Owner
Earthworks Health

2100 N. 13th St.
Norfolk, NE 68701
United States

Issuing Office:
Office of Human and Animal Food Division II West

United States

913-495-5100

Dear Mr. Smith:

The Food and Drug Administration has completed an evaluation of Welter Farms Inc. corrective actions in response to our Warning Letter (CMS case #: 560772) on June 28, 2019. Based on our evaluation, it appears that you have addressed the violation(s) 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/

Miguel A. Hernandez

Director, Compliance

Office of Human and Animal Food – Division II West