Aspen Sales Group

CLOSEOUT LETTER Aspen Sales Group MARCS-CMS 609365 — December 05, 2024 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Food & Beverages Recipient: Recipient Name Laurie Bogle Recipient Title CFO Aspen Sales Group 350 Main St., Suite 6A Bedminster , NJ 07921-2603 United States Issuing Office: Division of Northeast Imports United States Secondary Issuing Offices United States Dear Ms. Bogle, The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter CMS# 609365 dated October 07, 2020. Based on our evaluation, it appears that you have addressed the violation 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/ Anna Alexander Director, Compliance Branch Division of Northeast Imports-Compliance Branch U.S. Food and Drug Administration Content current as of: 12/12/2024 Regulated Product(s) Food & Beverages