Earthworks Health

CLOSEOUT LETTER Earthworks Health MARCS-CMS 560772 — February 04, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters 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 Content current as of: 02/05/2020 Regulated Product(s) Animal & Veterinary Dietary Supplements