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CLOSEOUT LETTER

CNMC Company, Inc.


CNMC Company, Inc.

  

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
 

July 24, 2015


 

Krishnan Suthanthiran, President
Best Medical International, Inc.
7643 Fullerton Road
Springfield, Virginia 22153

Dear Mr. Suthanthiran:

The Food and Drug Administration has completed an evaluation of the corrective actions of CNMC Company, Inc., located at 865 Easthagen Drive, Nashville, Tennessee, in response to our Warning Letter No. 2014-NOL-15, dated June 20, 2014. 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.

If you have any questions, I may be reached at (615) 366-7826.


Sincerely,

/S/

Kimberly A. Dutzek
Acting Director Compliance Branch
New Orleans District


cc: Thomas M. Kraus, Vice President
     CNMC Company, Inc.
     865 Easthaghen Drive
     Nashville, Tennessee 37217