Marli Washington Design, LLC

CLOSEOUT LETTER Marli Washington Design, LLC MARCS-CMS 720840 — March 27, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Product: Medical Devices Recipient: Recipient Name Marli Washington Recipient Title Manager Marli Washington Design, LLC 2502 Harford Rd Baltimore , MD 21218 United States legal@gc2b.info Issuing Office: Center for Devices and Radiological Health United States Secondary Issuing Offices United States Dear Marli Washington: The Food and Drug Administration (FDA) has completed an evaluation of Marli Washington Design, LLC d/b/a gc2b corrective actions in response to our Warning Letter CMS #720840, dated December 16th, 2025. 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/ Michael J. Hoffmann Office Director OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Marli Washington Marli Washington Design, LLC d/b/a gc2b cc: Shopify, Inc. abuse@shopify.com abuse@gc2b.co; support@gc2b.co Content current as of: 04/02/2026 Regulated Product(s) Medical Devices