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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Yuki Gosei Kogyo Co., Ltd. - Close Out Letter 11/23/2012


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 of International Drug Quality
10903 New Hampshire Avenue
Building #51, Room 4240
Silver Spring, MD 20993

TELEPHONE: (301) 796-3201
          FAX: (301) 847-8742

23 November 2012

Mr. Akito Nagai
Director Production Sector
Yuki Gosei Kogyo Co., Ltd
Ochiai 788 Joban Nishigo-machi
lwaki-shi, Fukushimi,
972-8316 Japan

Dear Mr. Nagai,


The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 320-11-04, dated December 9, 2010. 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.



Alicia Mozzachio
Branch Chief
Division of International Drug Quality