Inspections, Compliance, Enforcement, and Criminal Investigations

SUZUKEN CO., LTD. OGUCHI CENTER - Close Out Letter 9/14/15

  

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

 
 Food and Drug Administration
10903 New Hampshire Avenue
White Oak Building 66
Silver Spring, MD 20993

SEP 14 2015
 

Katsuya Iwasaki
General Manager
Kenz Product Department
Suzuken Co., Ltd ., Oguchi Center
58-1 1 Chome Sotoubo, Niwa-gun
Aichi 480-0125
JAPAN

Dear Mr. Iwasaki:

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to the Warning Letter (CMS #422711, dated June 11, 2014). Based on the Agency's evaluation, it appears that your firm has 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 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 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/

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

Page Last Updated: 09/17/2015
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