m4 Nutrition Companies LLC

CLOSEOUT LETTER m4 Nutrition Companies LLC MARCS-CMS 491534 — January 26, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: m4 Nutrition Companies LLC United States Issuing Office: United States 5001 Campus Drive College Park, MD 20740 January 26, 2018 Mathew W. Maynard M4 Nutrition Companies, LLC 7324 Gaston Ave Ste 124-422 Dallas, TX 75214-6126 Dear: Mr. Maynard, The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter Re: 491534, issued March 31, 2016. Based on our evaluation, it appears you have addressed the violation(s) contained in the 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/ Latasha A. Robinson, M.S. Branch Chief Dietary Supplement Labeling Assessment Branch Division of Enforcement Office of Compliance Center for Food Safety and Applied Nutrition Content current as of: 01/31/2018