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CLOSEOUT LETTER

Vertebral Technologies, Inc.


Vertebral Technologies, Inc.

 

  

Black HHS-Blue FDA Logo

 

 

 
Minneapolis District
260 Marquette Avenue, Suite 900
Minneapolis, MN S5401
(612) 758-7186 

February 15, 2017
 

Jeffrey C. Felt, M.D.
Chairman & Chief Executive Officer
Vertebral Technologies, Inc.
5909 Baker Road, Suite 550
Minnetonka, Minnesota 55345
 

Dear Dr. Felt:
 

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter MIN 15-16 dated September 4, 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 ensure 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/

Melissa I. Michurski
Compliance Officer
Minneapolis District