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CLOSEOUT LETTER

Tem Innovations GmbH 29/09/2016

TEM INNOVATIONS GMBH - Close Out Letter 9/29/16


Tem Innovations GmbH

  

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

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

 

SEPT 29, 2016
Dr. Thomas Ebinger
Chief Executive Officer (CEO)
Tem Innovations GmbH
Martin-Kollar-Strasse, 13-15
81829 Munich, Germany
 
Dear Dr. Ebinger:
 
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter [CMS#447892] dated April 21, 2015. 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/
James L. Woods
Deputy Director
Patient Safety and Product Quality
Office of In Vitro Diagnostics and Radiological Health
Center for Devices and Radiological Health