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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Ascension Orthopedics, Inc - Close Out Letter 9/16/11

  

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

Public Health Service
Food and Drug Administration
 

Dallas District Office
4040 North Central Expressway
Suite 300
Dallas, Texas 75204

September 16, 2011

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. Guy L. Mayer, President/CFO
Ascension Orthopedics, Inc.
8700 Cameron Road, Suite 100
Austin, TX 78754

Dear Mr. Mayer:

The Food and Drug Administration has completed an evaluation of (your/your firm's) corrective actions in response to our Warning Letter 2010-DAL-WL-16, September 16, 2010. 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.

Sincerely,

/s/

Shan J. Shambaugh
Director, Compliance Branch