Oregon’s Wild Harvest, Inc.

CLOSEOUT LETTER Oregon’s Wild Harvest, Inc. MARCS-CMS 621842 — April 19, 2023 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Overnight Delivery Product: Dietary Supplements Food & Beverages Recipient: Recipient Name Mark J. Vieceli Recipient Title Chief Executive Officer Oregon’s Wild Harvest, Inc. 1601 NE Hemlock Avenue Redmond , OR 97756 United States Issuing Office: Division of Human and Animal Food Operations West VI United States Dear Mr. Vieceli: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS 621842, dated July 8, 2022. 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/ Miriam R. Burbach Program Division Director Content current as of: 04/19/2023 Regulated Product(s) Dietary Supplements Food & Beverages