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  5. H2 Beverages, Inc. - 622917 - 03/22/2023
  1. Warning Letters

CLOSEOUT LETTER

H2 Beverages, Inc. MARCS-CMS 622917 —

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

 
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