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Eiken Chemical Company

Eiken Chemical Company

United States

Issuing Office:

United States


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

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.




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

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