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  5. Aionex Inc. - 08/01/2014
  1. Warning Letters


Aionex Inc.

Aionex Inc.

United States

Issuing Office:

United States


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

 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


August 1, 2014

Curt A. Freemyer, President and CEO
Aionex Inc.
104 Space Park North
Goodlettsville, Tennessee 37072

Dear Mr. Freemyer:

The Food and Drug Administration completed an evaluation of your firm's corrective actions in response to our Warning Letter No. 2013-NOL-06, dated January 9, 2013. 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 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.




Kari L. Batey
Acting Compliance Branch Director
New Orleans District 

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