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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

SpineFrontier, Inc. - Close Out Letter 9/20/13

  

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

 
 Food and Drug Administration
New England District Office
One Montvale Avenue, 4th floor
Stoneham, MA 02180
Phone 781.587.7500
      Fax 781.587.7556

 

September 20, 2013


Kingsley Chin
President
SpineFrontier, Inc.
500 Cummings Center
Suite 3500
Beverly, MA 01915-6126


Dear Mr. Chin:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter dated August 8, 2012, (#334199). Based on our evaluation, it appears that you have addressed the violation(s) 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 action should violations be observed during a subsequent inspection or through other means.

If you have any questions, please contact me at (781) 587-7491.

 

Sincerely,

/S/

Karen Archdeacon
Compliance Officer
New England District


Cc: Ms. Alyce Nelson
      Director, Quality Assurance and Regulatory Affairs
      SpineFrontier, Inc.
      500 Cummings Center
      Suite 3500
      Beverly, MA 01915-6126