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CLOSEOUT LETTER

Eiken Chemical Company 02/09/2014

Eiken Chemical Company - Close Out Letter 9/2/14


Eiken Chemical Company

  

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

Food and Drug Administration
 10903 New Hampshire Avenue
Silver Spring, MD 20993

 

SEP 02, 2014


Mr. Tetsuya Teramoto
President & CEO
Eiken Chemical Company
243 Nogi
Nogi-Machi, Shimotsuga-Gun
Toghigi, 329-0114
Japan


Dear Mr. Teramoto,

The Food and Drug Administration has completed an evaluation of Eiken Chemical Company's corrective actions in response to our Warning Letter Case # 392732, dated March 13, 2013. 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 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/

Alberto Gutierrez
Director
Office of InVitro Diagnostics and
Radiological Health
Center for Devices and Radiological
Health