Caliber Imaging & Diagnostics, Inc.

CLOSEOUT LETTER Caliber Imaging & Diagnostics, Inc. MARCS-CMS 431658 — November 06, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters 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 Content current as of: 11/16/2018 Regulated Product(s) Medical Devices