M Dialysis AB

CLOSEOUT LETTER M Dialysis AB MARCS-CMS 554169 — July 01, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Medical Devices Recipient: Recipient Name Olof Nord Recipient Title CEO M Dialysis AB Hammarby Fabriksvag 43 120 33 Stockholms Lan Sweden Issuing Office: Center for Devices and Radiological Health United States Dear Mr. Olof Nord: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 554169, dated June 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 yours, /S/ for Carlos Peña, Ph.D., M.S. Director Office of Health Technology 5 (OHT5): Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality (OPEQ) Center for Devices and Radiological Health (CDRH) CC: Kelly Nashawaty 73 Princeton Street #302 North Chelmsford, MA 01863 Olof.nord@mdialysis.se Content current as of: 05/09/2022 Regulated Product(s) Medical Devices