Total Nutrition Inc

CLOSEOUT LETTER Total Nutrition Inc MARCS-CMS 525508 — July 24, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Total Nutrition Inc United States Issuing Office: United States Office of Human and Animal Food Operations East Division 1 VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED July 24, 2018 Mr. Jay M. Silverman, President Total Nutrition, Inc. 75 Bi-County Boulevard Farmingdale, NY 11735 Dear Mr. Silverman: The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CMS# 525508, issued on August 16, 2017. 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/ CDR Catherine Beer Director, Compliance Branch Office of Human and Animal Food Operations East Division 1 Content current as of: 08/14/2018