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  5. Sonesta Medical AB - 667325 - 12/04/2023
  1. Warning Letters

CLOSEOUT LETTER

Sonesta Medical AB MARCS-CMS 667325 —

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

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