DBM Nutrition

CLOSEOUT LETTER DBM Nutrition MARCS-CMS 483226 — March 23, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: DBM Nutrition United States Issuing Office: United States 5001 Campus Drive College Park, MD 20740 March 23, 2018 Darin Booton DBM Nutrition 203 South Somonauk Road Cortland, IL 60112 Dear Mr. Booton: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter Re: 483226, issued November 30, 2015. 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 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: 03/27/2018