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  5. LED Dental Inc. - Close Out Letter 12/21/15
  1. Warning Letters

CLOSEOUT LETTER

LED Dental Inc.


LED Dental Inc.

  

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

 
 Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993

DEC 21 2015

David Morgan, Ph. D.
Chief Technical Officer
LED Medial Diagnostics, Inc.
LED Dental
5589 Byrne Road, Suite 235
Burnaby, British Columbia
Canada V5J 3J1

Dear Dr. Morgan:

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter (CMS# 423575, dated May 12, 2014). Based on our evaluation, it appears that your firm has adequately addressed the violations in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of theses corrections.

This letter does not relieve 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/

Keisha R. Thomas
Acting Division Director
Division of Premarket and
   Labeling Compliance
Office of Compliance
Center for Devices and
   Radiological Health


cc: Rebecca Brandt
     Latham & Watkins
     811 Main Street, Suite 3700
     Houston, Texas 77002