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Mentor Worldwide LLC MARCS-CMS 573520 —

Medical Devices

Recipient Name
Alenka Brzulja
Recipient Title
Worldwide President
Mentor Worldwide LLC

31 Technology Drive
Irvine, CA
United States

Issuing Office:
Center for Devices and Radiological Health

United States

Dear Alenka Brzulja:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS Case# 573520, dated March 18, 2019). 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.

Binita S Ashar, MD, MBA, FACS
Director OHT4
Office of Surgery and Infection Control Devices
Office of Product Quality and Evaluation
Center for Devices and Radiological Health
U.S. Food and Drug Administration

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