Great Healthworks, Inc.

CLOSEOUT LETTER Great Healthworks, Inc. MARCS-CMS 611686 — January 25, 2022 More Warning Letters Warning Letters About Warning and Close-Out Letters 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 Content current as of: 02/02/2022 Regulated Product(s) Dietary Supplements