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CLOSEOUT LETTER

TreyMed, Inc. Aug 21, 2017

TreyMed, Inc. - Close Out Letter 8/21/17


TreyMed, Inc.

 

  

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 

 
 

August 21, 2017

Robert H. Ricciardelli, President
TreyMed, Inc.
N56 W24790 North Corporate Circle, Suite C
Sussex, Wisconsin 53089-4378

Dear Mr. Ricciardelli:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter MIN 15-06 dated January 9, 2015. 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/

Melissa I. Michurski
Compliance Officer
Minneapolis District