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  5. G L E Gesellschaft Fur Lichttechnische Erzeugnisse Mbh 11/29/17
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G L E Gesellschaft Fur Lichttechnische Erzeugnisse Mbh 11/29/17

 

  

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10903 New Hampshire Avenue
Silver Spring, MD 20993
 

 
 

November 29, 2017
 

VIA UNITED STATES POSTAL SERVICE

Dr. Vera Muller
Chief Executive Officer
G L E Gesellschaft Fur Lichttechnische Erzeugnisse Mbh
Herzbergstr. 26
10365 Berlin
Germany

Dear Dr. Muller:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter (CMS# 508514, dated February 23, 2017). 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/
CAPT Raquel Peat, PhD, MPH
Director
Division of Premarket and Labeling Compliance
Office of Compliance
Center for Devices and Radiological Health