Healthtex Distributors, Inc.

CLOSEOUT LETTER Healthtex Distributors, Inc. MARCS-CMS 654453 — January 31, 2024 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Reference #: 24-HAFE4-WLCOL-02 Product: Dietary Supplements Recipient: Recipient Name Ms. Natividad R. Elias Recipient Title President and Owner Healthtex Distributors, Inc. 3555 NW 41st ST. Miami , FL 33142-4310 United States ybarreto@healthtexusa.com Issuing Office: Division of Human and Animal Food Operations East IV United States Secondary Issuing Offices United States Dear Mr. Elias: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to Warning Letter 23-HAFE4-WL-04 dated June 15, 2023. 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/ Pearl Lopina Director of Compliance Branch OHAFO, Division IV East Content current as of: 03/06/2024 Regulated Product(s) Dietary Supplements