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CLOSEOUT LETTER

Nanosphere, Inc.


Nanosphere, Inc.

 

  

Black HHS-Blue FDA Logo

 

 

 
Chicago District Office
550 W. Jackson Blvd., 15th Floor
Chicago, IL 60661
Telephone: (312) 353-5863
Fax: (312) 596-4187 

June 30, 2017

Mr. Nachum Shamir
President & CEO
Luminex Corporation previously Nanosphere, Inc.
4088 Commercial Ave
Northbrook, IL 60062

Dear Mr. Shamir:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter, CHI-1-15 dated January 21, 2015. 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/

William R. Weissinger
District Director