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Nippon Fine Chemical Co., LTD

Nippon Fine Chemical Co., LTD

United States

Issuing Office:

United States



Black HHS-Blue FDA Logo



10903 New Hampshire Avenue
Silver Spring, MD  20993 

March 23, 2017

Mr. Hiromichi Kaneko, General Manager
Nippon Fine Chemical Co
1-1, 5- Chome, Umei
Takasago City, Hyogo 676-0074

Reference: FEI 3001722961

Dear Mr. Kaneko:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-16-35 dated September 26, 2016. 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.

LaKeesha M. Foster
Consumer Safety Officer
Global Compliance Branch 4

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