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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

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Express Diagnostics International, Inc. - Close Out Letter 10/14/11

  

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

Public Health Service
Food and Drug Administration
 

Minneapolis District Office
Central Region
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 758-7133
FAX: (612) 334-4142
 

October 14, 2011

 

Paul K. Johnson
Chief Executive Officer
Express Diagnostics International, Inc.
1550 Industrial Drive
Blue Earth, Minnesota 56013

Dear Mr. Johnson:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter MIN 11-16 dated March 24, 2011. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. We have also completed our review of the issues involving 510(k) coverage of your devices. 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/

Timothy G. Philips
Compliance Officer
Minneapolis District

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