Genetic Edge Compounds

CLOSEOUT LETTER Genetic Edge Compounds MARCS-CMS 510403 — June 05, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Genetic Edge Compounds United States Issuing Office: United States Office of Human and Animal Food Operations West Division 3 4040 North Central Expressway, Suite 300 Dallas, Texas 75204 May 29, 2018 UPS OVERNIGHT Bradley N. Howard, Owner and CEO Genetic Edge Compounds, LLC (b)(6), (b)(7)(C) McKinney, Texas 75070 Mr. Howard: The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter 2017-DAL-WL-15, dated April 14, 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. If you choose to reestablish or sell your operations, 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/ Jessica E. Hensley Director, Compliance Branch Office of Human and Animal Foods, West - Division 3 Content current as of: 06/11/2018