CLOSEOUT LETTER

Great Healthworks, Inc. MARCS-CMS 611686 — January 25, 2022

Delivery Method:: VIA Electronic Mail
Reference #:: 21-HAFE4-WL-06
Product:: Dietary Supplements

Recipient:: Recipient Name

Mr. Ken Meares; Recipient Title

Chief Executive Officer; Great Healthworks, Inc.; 4150 SW 28th Way
Fort Lauderdale, FL 33312-5201
United States; komorris@greathealthworks.com; lpagan@healthworks.com

Issuing Office:: Office of Human and Animal Food Operations, Division IV East; United States; (787) 729-8500

Dear Mr. Meares:

The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter, 21-HAFE4-WL-06 dated June 23, 2021. 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/
Pearl Lopina
Director of Compliance Branch
Office of Human and Animal Food
Operations, East Division IV