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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Arrowhead DE LLC - Close Out Letter 4/16/13

  

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

Public Health Service
Food and Drug Administration
 New Orleans District
404 BNA Drive
Building 200- Suite 500
Nashville, TN 37217

Telephone: (615) 366-7801
         FAX: (615) 366-7802

 

April 16, 2013

 


Patrick T. Mullaney, President
Arrowhead Medical Device Technologies, LLC
328 Poplar View Lane East, Suite 2
Collierville, Tennessee 38017


Dear Mr. Mullaney:


The Food and Drug Administration (FDA) completed an evaluation of your firm's corrective actions in response to our Warning Letter No. 2012-NOL-21 dated May 18, 2012. Based on our evaluation, it appears 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 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 FDA expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter does not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.


Sincerely,

/S/

Ruth P. Dixon
Compliance Branch Director
New Orleans District