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  5. Dako Denmark A/S - 04/15/2015
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Dako Denmark A/S

Dako Denmark A/S

United States

Issuing Office:

United States


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

Public Health Service
Food and Drug Administration

10903 New Hampshire Avenue
White Oak Building 66
Silver Spring, Maryland 20993 


April 15, 2015

Mr. Simon Ostergaard
Country General Manager Denmark
Dako Denmark A/S
Produktionsvej 42
2600 Glostrup, Denmark

Dear Mr. Ostergaard: 


The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 406109 dated August 21, 2013. 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.

Alberto Gutierrez -S
Alberto Gutierrez, Ph.D.
Office of In Vitro Diagnostics and
Radiological Health
Center for Devices and Radiological Health

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