Organa International Corp.

CLOSEOUT LETTER Organa International Corp. MARCS-CMS 613018 — September 30, 2024 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Product: Dietary Supplements Recipient: Recipient Name Laurence M. Mills Recipient Title Owner Organa International Corp. 533 N 1650 W Springville , UT 84663 United States larry@organa.net Issuing Office: Office of Human and Animal Food Operations Division West 4 United States Secondary Issuing Offices United States Dear Mr. Mills: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS Case # 613018, dated October 13, 2021. 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/ E. Mark Harris Program Division Director Office of Human and Animal Food Operations – West Division 4 Content current as of: 10/04/2024 Regulated Product(s) Dietary Supplements