HoneyCombs Industries, LLC

CLOSEOUT LETTER HoneyCombs Industries, LLC MARCS-CMS 481691 — March 18, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Reference #: DEN-16-06-WL Product: Dietary Supplements Recipient: Recipient Name Ms. Jacqueline Huff Recipient Title General Manager HoneyCombs Industries, LLC 10671 60.75 Road Montrose , CO 81403 United States Issuing Office: Office of Human and Animal Food Operations Division IV West United States Dear Ms. Huff: The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter DEN-16-06-WL dated February 24, 2016. 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, Ph.D. Program Division Director Office of Human and Animal Food Operations Division IV West Content current as of: 03/20/2020 Regulated Product(s) Dietary Supplements