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  5. MEDINVENTS NV - Close Out Letter 12/9/14
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CLOSEOUT LETTER

MEDINVENTS NV


MEDINVENTS NV

  

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

 
 Food and Drug Administration
10903 New Hampshire A venue
White Oak Building 66
Silver Spring, MD 20993

 

DEC 09, 2014
 

Johan Janssens
Chief Operations Officer
Medinvents NV
Kuringersteenweg 304
B-3500 Hasselt
Belgium


Dear Mr. Janssens:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter #396903, dated June 6, 2013. Based on our evaluation, it appears that your firm has 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/

Carl Fischer, Ph.D.
Acting Director
Division of International Compliance
Operations
Office of Compliance
Center for Devices and
   Radiological Health