Niche Pharmaceuticals, Inc

CLOSEOUT LETTER Niche Pharmaceuticals, Inc MARCS-CMS 553911 — August 13, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: UPS Product: Food & Beverages Recipient: Recipient Name Stephen F. Brandon, Sr. Recipient Title Owner & CEO Niche Pharmaceuticals, Inc 580 Commerce Street Ste. 100 Southlake , TX 76092-9156 United States Issuing Office: Center for Food Safety and Applied Nutrition 4040 North Central Expressway Suite 300 Dallas , TX 75204-3138 United States Dear Mr. Brandon: The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter (CMS Case #: 553911) on June 19, 2018. 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/ Dana M. Lewis Compliance Officer Office of Human and Animal Food-West Div. 3 Content current as of: 08/15/2019 Regulated Product(s) Food & Beverages