Inspections, Compliance, Enforcement, and Criminal Investigations
VertiFlex, Inc. - Closeout letter
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Los Angeles District|
Irvine, CA 92612-2506
December 15, 2010
Earl R. Fender
President and CEO
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.
Director, Compliance Branch
Los Angeles District