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

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