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CLOSEOUT LETTER

Fujifilm Corporation MARCS-CMS 546987 —

Product:
Medical Devices
Recipient:
Recipient Name
Henry Izawa
Recipient Title
President and CEO
Fujifilm Corporation

419 West Avenue
Stamford, CT 06902
United States

Issuing Office:
Center for Devices and Radiological Health

United States

Dear Henry Izawa:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 546987, dated March 9, 2018). Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter.

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.

Sincerely yours,
/S/
Courtney H. Lias, Ph.D.
Director
OHT3: Office of GastroRenal, ObGyn,
General Hospital and Urology Devices
Center for Devices and Radiological Health


CC:

Randy Vader
Vice President, Quality and Regulatory Affairs and Corporate Compliance Officer
Fujifilm Medical Systems U.S.A., Inc.
419 West Avenue
Stamford, Connecticut 06902

Keith Nelson
Director of Infection Control and Quality Assurance
10 Highpoint Drive
Wayne, New Jersey 07470

Mr. Teiichi Goto
Corporate Vice President
General Manager
Medical System Business Division
Research & Development Management Headquarters
Fujifilm Corporation
798, Miyanodai Kaisei-Machi
Ashigarakami-Gun
Kanagawa 258-8538 Japan

Jennifer Henderson
Partner, Hogan Lovells US LLP
Columbia Square
555 Thirteenth Street, NW
Washington, DC 20004

John J. Smith, MD, JD
Legal Counsel at Hogan Lovells US LLP
Columbia Square
555 Thirteenth Street, NW
Washington, DC 20004US AGENT
US AGENT ADDRESS

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