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  5. Doro, Inc. - 446370 - 04/29/2016
  1. Warning Letters


Doro, Inc. MARCS-CMS 446370 —

Delivery Method:
United Parcel Service
Medical Devices

Recipient Name
Douglas Gervais
Recipient Title
Doro, Inc.

24-174 Colonnade Road
Ottawa ON K2E 7J5

Issuing Office:
Center for Devices and Radiological Health

10903 New Hampshire Avenue
Silver Spring, MD 20993
United States

Dear Mr. Gervais:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter (WL #446370 dated March 9, 2015). 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,
Carl Fischer, Ph.D.
Division of International Compliance Operations
Office of Compliance
Center for Devices and Radiological Health

U.S. Agent
Rene Van De Zande
Emergo Global Representation, LLC
816 Congress Avenue, Suite 1400
Austin, Texas 78701

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