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  5. M Dialysis AB - 554169 - 07/01/2020
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M Dialysis AB MARCS-CMS 554169 —

Medical Devices

Recipient Name
Olof Nord
Recipient Title
M Dialysis AB

Hammarby Fabriksvag 43
120 33 Stockholms Lan

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,
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)

Kelly Nashawaty 73 Princeton Street
North Chelmsford, MA 01863 Olof.nord@mdialysis.se

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