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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Fukuda Denshi Co, Ltd - Close Out Letter 5/8/13

  

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

Public Health Service
Food and Drug Administration
 10903 New Hampshire A venue
White Oak Building 66
Silver Spring, MD 20993

 

MAY 08, 2013

 


Mr. Kotaro Fukuda
President and CEO
Fukuda Denshi Co, Ltd
39-4 Hongo-3-Chome, Bunkyo-Ku
Tokyo, 113-8483
Japan


Dear Mr. Fukuda:

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

William C. MacFarland
Director
Division of Enforcement B
Office of Compliance
Center for Devices and Radiological Health