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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Novo Nordisk A/S - Close Out Letter 1/23/14

  

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

Public Health Service
Food and Drug Administration
 CENTER FOR DRUG EVALUATION AND RESEARCH
Office of Manufacturing and Product Quality
Division International Drug Quality
International Compliance Branch
10903 New Hampshire Avenue
Building #51, Room 4223
Silver Spring, MD 20993

TELEPHONE: (240) 402-4131
FAX: (301) 847-8742

 

January 23, 2014


Mr. Lars Guldbaek Karlsen
Senior Vice President
Novo Nordisk A/S
Vandtarnsvej 83A
DK-2860 Soborg, Denmark


Reference: 3000151819


Dear Mr. Karlsen:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter #320-13-03 dated December 12, 2012. 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.

 

Sincerely,

/S/

Thuy T. Nguyen
Compliance Officer
Division of lnternational Drug Quality