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  5. LIV Health LLC dba INFINIWELL and DEAL Media LLC dba HARMONIA - 613114 - 05/25/2022
  1. Warning Letters

CLOSEOUT LETTER

LIV Health LLC dba INFINIWELL and DEAL Media LLC dba HARMONIA MARCS-CMS 613114 —

Delivery Method:
Via Email
Product:
Dietary Supplements
Food & Beverages
Recipient:
Recipient Name
Roger Frantz and Jeremy S. Delk
LIV Health LLC dba INFINIWELL and DEAL Media LLC dba HARMONIA

881 Corporate Drive
Lexington, KY 40503
United States

Jeremy.Delk@delkinc.com
Issuing Office:
Office of Human and Animal Foods Operations‐East V

United States

Dear Messrs. Frantz and Delk:

The Food and Drug Administration (FDA) completed an evaluation of your firm’s corrective actions in response to our Warning Letter No. 613114. Based on our evaluation, it appears 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/
Zada L. Giles
Compliance Officer, Division V
Office of Human and Animal Foods Operations-East
Cc: Dustin Cappelletto, CEO via Dustin@livhealth.com

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