Natural Alchemist

CLOSEOUT LETTER Natural Alchemist MARCS-CMS 513852 — July 03, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Natural Alchemist United States Issuing Office: United States 1431 Harbor Bay Parkway Alameda, CA 94502-7070 July 03, 2018 Mr. Will Claren, CEO Natural Alchemist, Alurent Inc. 3941 Park Drive El Dorado Hills, CA 95762 Dear Mr. Will Claren: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 513852), dated October 31, 2017. Based on our evaluation, it appears that you have addressed the violation(s) 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/ Sergio Chavez, Director of Compliance Office Human and Animal Foods Division West 5 Content current as of: 07/09/2018