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  5. International Medsurg Connection, Inc. - 511426 - 10/16/2018
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International Medsurg Connection, Inc. MARCS-CMS 511426 —

Recipient Name
Omi Bhati
Recipient Title
International Medsurg Connection, Inc.

935 N Plum Grove Road Suite F
Schaumburg, IL 60173-4770
United States

Issuing Office:
Center for Devices and Radiological Health

550 W. Jackson Blvd.
15th Floor
Chicago, IL 60661
United States

Dear Dr. Bhati:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CHI-09-118 dated May 08, 2017. 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.

Blake Bevill, MS
Program Division Director
OMDRHO Division 2 - Central

CC:  Kane Ouano, Quality Compliance Manager
        : Dean Sprake Jones, Quality Manager

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