Mega Pro International

CLOSEOUT LETTER Mega Pro International MARCS-CMS 527374 — August 31, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Mega Pro International United States Issuing Office: United States U.S. Food and Drug Administration 6th Ave & Kipling St, DFC Bldg 20 PO Box 25087 Denver, CO 8022-0087 August 31, 2018 VIA UPS OVERNIGHT David V. Smith, Owner Mega-Pro Nutrition, Inc. 251 Hilton Drive St George, UT 84 790 Dear Mr. Smith: The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter HAF4W(DEN)-17-17-WL dated August 25, 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/ LaTonya M. Mitchell Program Division Director Office of Human and Animal Food Operations - Division IV West Content current as of: 09/11/2018