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CLOSEOUT LETTER

Spinal Elements, Inc 01/11/2017

Spinal Elements, Inc - Close Out Letter 11/1/17


Recipient:
Spinal Elements, Inc


United States

Issuing Office:

United States


 

  

Black HHS-Blue FDA Logo

 

Office of Medical Devices and Radiological Health Operations
Division 3 West
19701 Fairchild
Irvine, CA 92612

 
 

UNITED PARCEL SERVICE
SIGNATURE REQUIRED

11/01/2017

CMS 421804 FY2017

Jason D. Blain
President
Spinal Elements, Inc.
3115 Melrose Drive, Suite 200
Carlsbad, California 92010

Dear Mr. Blain:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 21-14 dated June 12, 2014. 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,
/S/

Kelly D. Sheppard
Director, Compliance Branch