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CLOSEOUT LETTER

Navilyst Medical, Inc.


Navilyst Medical, Inc.

  

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

 
 New York District
Food & Drug Administration
158-15 Liberty Avenue
Jamaica, NY 11433

November 25, 2015
 

Joseph M. DeVivo
President and Chief Executive Officer
Navilyst Medical Inc., an AngioDynamics Company
14 Plaza Drive
Latham, NY 12110

Dear Mr. DeVivo:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter, NYK-2015-5, issued on November 4, 2014. Based on our evaluation of your written responses and follow-up inspections, 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 yours,

/S/

Lillian C. Aveta
Compliance Officer
FDA-New York District