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NuVasive, Inc.

NuVasive, Inc.

United States

Issuing Office:

United States


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

Public Health Service
Food and Drug Administration
Los Angeles District
 19701 Fairchild
Irvine, California 92612-2506
Telephone (949) 608-2900
Fax              (949) 608-4415



March 4, 2014

Keith C. Valentine
President and Chief Operating Officer
NuVasive, Inc.
7475 Lusk Blvd.
San Diego, California 92121

Dear Mr. Valentine:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter, W/L 27-13, dated March 12, 2013. 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 the 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 the firm to maintain compliance and will continue to monitor their state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.




Blake Bevill
Director, Compliance Branch
Los Angeles District Office

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