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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Spineology, Inc. - Close Out Letter 6/28/12

  

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

Public Health Service
Food and Drug Administration
 

10903 New Hampshire Ave.
Silver Spring, MD 20993-0002

 

JUN 28, 2012

Mr. John Booth
CEO
Spineology, Inc.
7800 3rd St. N
Suite 600
Saint Paul, MN 55128-5451

Dear Mr. Booth:

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter of September 22, 2010. Based on our evaluation, it appears that your firm has 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 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 FDA expects your firm to maintain compliance and will continue to monitor your firm's 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 yours,

/S/

Steven D. Silverman
Director
Office of Compliance
Center for Devices and
Radiological Health Chief