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  5. VE Valley Electronics GmbH - 01/23/2014
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VE Valley Electronics GmbH

VE Valley Electronics GmbH

United States

Issuing Office:

United States


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

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


JAN 23, 2014

Hubertus Rechberg
VE Valley Electronics GmbH
Breite 2
Murnau Am Staffelsee D-82418, Germany

Dear Mr. Rechberg:

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter [CMS# 392454] dated March 1, 2013. Based on our evaluation, it appears that you have addressed the violation 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,


Steven D. Silverman
Office of Compliance
Center for Devices and
   Radiological Health


U.S. Agent
Jessica Griger
Valley Electronics LLC
25505 Collins Wharf Road
Eden, Maryland 21822

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