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  5. Spine Smith Holdings, LLC - 09/29/2015
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Spine Smith Holdings, LLC

Spine Smith Holdings, LLC

United States

Issuing Office:

United States


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

Food and Drug Administration
 Dallas District Office
4040 North Central Expressway
Suite 300
Dallas, Texas 75204

September 29, 2015


Steve Melchiode, President
Spine Smith Holdings, LLC
dba Celling Biosciences
93 Red River Street
Austin, Texas 78701

Dear Mr. Melchiode:

The Food and Drug Administration has completed an evaluation of your firm's inspectional history since receiving Warning Letter 2013-DAL-WL-035 issued on April 3, 2013. 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.



Shari J. Shambaugh
Director, Compliance Branch
Dallas District Office


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