ICA Health, LLC

CLOSEOUT LETTER ICA Health, LLC MARCS-CMS 614383 — October 16, 2023 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Dietary Supplements Recipient: Recipient Name Dr. James L. Wilson Recipient Title Owner/Manager ICA Health, LLC Future Formulations, LLC 1340 E. 20th Street Tucson , AZ 85719-6710 United States Issuing Office: Office of Human and Animal Foods Operations – Division West 4 United States Dear Dr. Wilson, The Food and Drug Administration has completed an evaluation of ICA Health, LLC and Future Formulations, LLC corrective actions in response to our Warning Letter (CMS case #614383) issued on September 20, 2021. 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/ E.Mark Harris Program Division Director Office of Human and Animal Food Operations – West Division 4 Content current as of: 10/24/2023 Regulated Product(s) Dietary Supplements