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Ferrosan Medical Devices A/s

Ferrosan Medical Devices 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
Silver Spring, MD 20993 

NOV 9, 2015

Via United Parcel Service

Mr. Henrik Krois
Ferrosan Medical Devices A/S
Sydmarken 5
DK-2860 Soeborg

Dear Mr. Krois:

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter dated September 16, 2015. Based on our evaluation, it appears that you have addressed the violation 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.

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


Shikha Gola
U.S. Agent
Ethicon Inc.
Route 22 West
Somerville, New Jersey 08876

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