Line One Nutrition, Inc

CLOSEOUT LETTER Line One Nutrition, Inc MARCS-CMS 562618 — June 19, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Dietary Supplements Recipient: Recipient Name Andrew Dean McMichael Recipient Title President Line One Nutrition, Inc 2607 N. River Hills Rd. Austin , TX 78733 United States Issuing Office: CFSAN Office of Compliance 5001 Campus Drive College Park , MD 20740 United States Dear Mr. McMichael: The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter, CMS #562618, dated April 10, 2019. 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/ Carrie Lawlor Branch Chief Dietary Supplement and Labeling Assessment Branch Division of Enforcement Office of Compliance Center for Food Safety and Applied Nutrition Content current as of: 10/08/2019 Regulated Product(s) Dietary Supplements