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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Kyowa Hakko Bio Co., Ltd. - Close Out Letter 1/19/12


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

Public Health Service
Food and Drug Administration

Office of Manufacturing and Product Quality
Division International Drug Quality
International Compliance Team
10903 New Hampshire Avenue
Building #51, Room 4219
Silver Spring, MD 20993
TELEPHONE: (301) 796-3194
FAX: (301) 847-8742


Mr. Shigenori Ishizaki
Director of the Board/Plant Director
Yamaguchi Production Center
Kyowa Hakko Bio Co., Ltd.
1-1, Kyowa-cho
Hofu City, Yamaguchi
Japan 747-8522

Reference: FEI 3002807424

Dear Mr. Ishizaki:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 320-10-009 issued on September 29, 2010. 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.



Brian L. Belz
Compliance Officer
Division of International Drug Quality