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CLOSEOUT LETTER

Coapt LLC Jun 12, 2017

Coapt LLC - Close Out Letter 6/12/17


Coapt LLC

 

  

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

June 12, 2017

Mr. Blair A. Lock
Chief Executive Officer (CEO)
Coapt, LLC
222 W. Ontario Street, Unit # 220
Chicago, Illinois 60654

Dear Mr. Lock:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CHI-2-16 dated January 8, 2016. 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