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  5. Caliber Imaging & Diagnostics, Inc. - 431658 - 11/06/2018
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CLOSEOUT LETTER

Caliber Imaging & Diagnostics, Inc. MARCS-CMS 431658 —

Product:
Medical Devices

Recipient:
Recipient Name
L. Michael Hone
Recipient Title
Chief Executive Officer
Caliber Imaging & Diagnostics, Inc.

50 Methodist Hill Drive
Suite 1000
Rochester, NY 14623
United States

Issuing Office:
Center for Devices and Radiological Health

10903 New Hampshire Avenue
Silver Spring, MD 20993
United States


Dear Mr. Hone:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS# 431658) dated January 8, 2015. Based on our evaluation, it appears that your firm has 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 Anne M. Ferriter
Director, Division of Analysis and Program
Operations
Office of Compliance
Center for Devices and Radiological Health

cc:
Kristin Davenport
Covington & Burling LLP
One CityCenter, 850 Tenth Street, NW
Washington, DC 20001

 
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