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  5. G L E Gesellschaft Fur Lichttechnische Erzeugnisse Mbh - 508514 - 11/29/2017
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CLOSEOUT LETTER

G L E Gesellschaft Fur Lichttechnische Erzeugnisse Mbh MARCS-CMS 508514 —

Delivery Method:
United States Postal Service
Product:
Medical Devices

Recipient:
Recipient Name
Dr. Vera Muller
Recipient Title
Chief Executive Officer
G L E Gesellschaft Fur Lichttechnische Erzeugnisse Mbh

Herzbergstr. 26
10365 Berlin
Germany

Issuing Office:
Division of Premarket and Labeling Compliance

United States


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

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