Sonesta Medical AB

CLOSEOUT LETTER Sonesta Medical AB MARCS-CMS 667325 — December 04, 2023 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Medical Devices Recipient: Recipient Name Pelin Sari Recipient Title Chief Executive Officer Sonesta Medical AB Industrivagen 7 171 48 Solna Sweden Pelin.Sari@sonestamedical.se Issuing Office: Center for Devices and Radiological Health United States Secondary Issuing Offices United States Dear Ms. Sari, The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS Case No. 667325, dated September 22, 2023). 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/ Robert Ochs, Ph.D. Director OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Cc: Greg Swanson U.S. Agent Emergo Global Representation LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, Texas 78746 USAgent@UL.com Mark D. Boesen mboesen@bslawusa.com Content current as of: 02/28/2024 Regulated Product(s) Medical Devices