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  5. Cardiac Designs Inc. - Close Out Letter 8/29/16
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CLOSEOUT LETTER

Cardiac Designs Inc. Aug 29, 2016

Cardiac Designs Inc. - Close Out Letter 8/29/16


Cardiac Designs Inc.

  

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

Food and Drug Administration
 Dallas District Office
4040 North Central Expressway
Suite 300
Dallas, Texas 75204

August 29, 2016


UPS Overnight

Robert D. Jordan, President
Cardiac Designs, Inc.
25510 Interstate 45 North
Spring, Texas 77386

Dear Mr. Jordan:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter 2015-DAL-WL-26. 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/

Shari J. Shambaugh
Director, Compliance Branch