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Sekisui Medical Co., Ltd. MARCS-CMS 507037 —

Sekisui Medical Co., Ltd.

United States

Issuing Office:

United States



Black HHS-Blue FDA Logo



10903 New Hampshire Avenue
Silver Spring, MD 20993 

October 5, 2017

Mr. Homare Tachiyanagi, General Manager
Sekisui Medical Co. Ltd.
Iwate Fractory
4-11 5 Matsuo
Hachimantai. Iwate. 028-7305

Reference: FET 3002806840

Dear Mr. Tachiyanagi:

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter: 320-17-04 dated November 8, 2016. Based on our evaluation, it appears that you have addressed the deviations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter docs 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 FDA expects you and your firm to maintain compliance with current good manufacturing practices and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should deviations be observed during a subsequent inspection or through other means.

Runa Musib, Ph.D.
Compliance Officer
Division of Drug Quality II

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