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CLOSEOUT LETTER

Sekisui Medical Co., Ltd Dec 20, 2016

Sekisui Medical Co., Ltd - Close Out Letter 12/20/16


Sekisui Medical Co., Ltd

  

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 

DEC 20, 2016

Hideo Tagashira
President and CEO
Sekisui Medical Co., Ltd.
3-3-1, Koyodai, Ryugasaki-Shi
lbaraki-ken, Japan 301-0852

Dear Mr. Tagashira:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter [CMS#437829] dated October 17, 2014. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustain ability 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/

James L. Woods
Deputy Director
Patient Safety and Product Quality
Office of In Vitro Diagnostics and
     Radiological Health
Center for Devices and Radiological Health