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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Alphatec Spine, Inc - Close Out Letter 9/28/11

  

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 

Los Angeles District
Pacific Region
19701 Fairchild
Irvine, CA 92612·2506
Telephone: 949-608-2900
FAX: 949-608-4415
 


CERTIFIED MAIL
RETURN RECEIPT REQUESTED

September 28, 2011

Dirk M. Kuyper
President and Chief Executive Officer
Alphatec Spine, Inc.
5818 El Camino Real
Carlsbad, California 92008-8816
Dear Mr. Kuyper:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter (WL #27-10 dated June 21, 2010). 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 film 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/

Alonza E. Cruse
District Director
Los Angeles District