Inspections, Compliance, Enforcement, and Criminal Investigations
Alphatec Spine, Inc - Close Out Letter 9/28/11
| Public Health Service Food and Drug Administration |
Los Angeles District |
Department of Health and Human Services
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
