- Dako Denmark A/S
Department of Health and Human Services
Public Health Service
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
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
Center for Devices and Radiological Health