Mannatech Incorporated

CLOSEOUT LETTER Mannatech Incorporated MARCS-CMS 521321 — January 03, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA UPS Reference #: 2018-DAL-WL-2 Product: Dietary Supplements Recipient: Recipient Name Alfredo Bala Recipient Title President Mannatech Incorporated 600 South Royal Lane Coppell , TX 75019 United States Issuing Office: Office of Human and Animal Food-West Div. 3 United States 214-253-5200 Dear Mr. Bala: The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter (2018-DAL-WL-2) issued on November 14, 2017. 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/ Casey Hamblin Recall Coordinator/Compliance Officer Office of Human and Animal Food-West Div. 3 Content current as of: 01/06/2020 Regulated Product(s) Dietary Supplements