CLOSEOUT LETTER
Herbal Vitality, Inc. MARCS-CMS 640206 —
- Product:
- Medical Devices
- Recipient:
-
Recipient NameYvan P. Rochon, PhD
-
Recipient TitlePresident
- Herbal Vitality, Inc.
2810 Hopi Drive
Sedona, AZ 86336
United States-
- herbalvitality@sedona.net
- Issuing Office:
- Division of Human and Animal Food Operations West IV
United States
United States
Dear Dr. Rochon:
The Food and Drug Administration has completed the evaluation of your firm’s corrective actions in response to our Warning Letter #640206, issued on March 7, 2023. Based on our evaluation, it appears the 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/
Carrie Lawlor, Branch Chief
Dietary Supplements Enforcement Branch
Office of Compliance and Enforcement
Human Foods Program
U.S. Food and Drug Administration