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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Medibo N.V. - Close Out Letter 1/10/11


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


JAN 10 2011

VIA United Parcel Services
Mr. Jos Bollen
Managing Director
Heikant 5,
3930 Hamont-Achel, Belgium

Dear Mr. Bollen:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter issued on October 2, 2009. Based on our evaluation, it appears that you have addressed the violations related to 21 CFR 803.50 and 21 CFR 803.18, contained in the Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve 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 your firm to maintain compliance and will continue to monitor your firm's state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.



Gregory W. O'Connell
Acting Director,
Division of Enforcement A
Office of Compliance
Center for Devices and
Radiological Health