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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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VertiFlex, Inc. - Closeout letter


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: 949-606-2900

December 15, 2010

Earl R. Fender
President and CEO
VertiFlex, Inc.
1351 Calle Avanzado
San Clemente, California 92673-6351

Re: Dynabolt™ Rods (VeltiFlex™ Spinal System)

Dear Mr. Fender:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter WL#30-10 of July 14, 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 firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory activities should violations be observed during a subsequent inspection or through other means.

If you have any questions or comments, please contact Compliance Officers Scott Goff at 949-608-4433.



Blake Bevill
Director, Compliance Branch
Los Angeles District