H2 Beverages, Inc.

CLOSEOUT LETTER H2 Beverages, Inc. MARCS-CMS 622917 — March 22, 2023 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: UPS Overnight Product: Dietary Supplements Recipient: Recipient Name Kurt H Ruppman, Sr. Recipient Title CEO/President H2 Beverages, Inc. 1601 Summit Ave. Suite. 100 Plano , TX 75074-8109 United States Issuing Office: Division of Human and Animal Food Operations West III United States Secondary Issuing Offices United States Dear Mr. Ruppman: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS 622917 dated June 14, 2022) issued following an inspection of your beverage manufacturing and distribution facility, located at 1601 Summit Ave Ste. 100, Plano, TX 75074-8109. 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/ Jessica E. Havranek Director, Compliance Branch Human & Animal Food Operations, West Division 3 Cc: Lori Woznicki, Food and Drug Inspections Branch Manager Division of Regulatory Services Texas Department of State Health Services 1100 E. 49th Street – Mail Code 1987 Austin, Texas 78756 Content current as of: 12/14/2023 Regulated Product(s) Dietary Supplements