Lone Star Botanicals Inc.

CLOSEOUT LETTER Lone Star Botanicals Inc. MARCS-CMS 659735 — June 25, 2024 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Food & Beverages Recipient: Recipient Name Tommy W. Kerzee Recipient Title Owner Lone Star Botanicals Inc. 2001 Broussard St. Tyler , TX 75701-8406 United States Issuing Office: Division of Human and Animal Food Operations East III United States Secondary Issuing Offices United States Dear Mr. Kerzee, The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter dated November 6, 2023, issued following inspection of your facility located at 2001 Broussard St., Tyler, TX 75701. 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. If you choose to reestablish or sell your operations, 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/ Chad J. Whitwell Acting Director, Compliance Branch Office of Human and Animal Food, WD3 Content current as of: 07/01/2024 Regulated Product(s) Food & Beverages