Aegle Nutrition LLC

CLOSEOUT LETTER Aegle Nutrition LLC MARCS-CMS 546966 — August 04, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA UPS and Electronic Mail Product: Dietary Supplements Recipient: Recipient Name John Ramsey Recipient Title President Aegle Nutrition LLC 1300 Hutton Drive Suite 110 Carrollton , TX 75006 United States Issuing Office: Office of Human and Animal Food-West Div. 3 United States 214-253-5200 Dear Mr. Ramsey: The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter (CMS Case #: 546966) on July 6, 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: 08/05/2020 Regulated Product(s) Dietary Supplements