Inspections, Compliance, Enforcement, and Criminal Investigations

Express Diagnostics Int'l., Inc. - Close Out Letter 10/18/17

 

  

Black HHS-Blue FDA Logo

 

Office of Medical Devices and Radiological Health Operations (OMDRHO), Division 2 - Central
555 Winderley Place, Suite 200
Maitland, FL 32751
(407) 475-4700 

 
 

October 19, 2017

Paul Johnson
CEO and President
Express Diagnostics International, Inc.
1550 Industrial Drive, P.O. Box 310
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 MN 14-23. Based on our evaluation, it appears that 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.

Sincerely,
/S/

Timothy G. Philips
Compliance Officer
Minneapolis District 

Page Last Updated: 10/23/2017
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