CLOSEOUT LETTER

Olympus Corporation of the Americas MARCS-CMS 470191 — June 07, 2017

Product:: Medical Devices

Recipient:: Recipient Name

Akihiro Okubo; Recipient Title

President; Olympus Corporation of the Americas; 2951 Ishikawa-cho
Hachioji-shi
Tokyo
192-8507
Japan

Issuing Office:: Center for Devices and Radiological Health; Silver Spring, MD 20993-0002
United States

Dear Mr. Okubo:

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter dated August 12, 2015. Based on our evaluation, it appears that your firm has adequately addressed the violations contained in this Warning Letter.

This letter does not relieve 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. The FDA expects your firm to maintain compliance and this letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

Sincerely yours,
/S/

Valerie A. Flournoy, MS
Deputy Director
Division of Manufacturing and Quality
Office of Compliance
Center for Devices and
Radiological Health Chief

cc:
Kazuhisa Otani, President
Aizu Olympus Co., Ltd.
500 Aza Muranishi Ooaza
Niidera, Monden-Machi
Aizuwakamatsu-shi, Fukushima, 965-8520
Japan

Laura Storms, Vice President
Regulatory/ Clinical Affairs & Quality Assurance
Olympus Corporation of the Americas,
3500 Corporate Parkway
Center Valley, Pennsylvania 18034
U.S.A.

Donny J. Shapiro, Director
Regulatory Affairs and Quality Assurance
Olympus Corporation of the Americas
2400 Ringwood Avenue
San Jose, California 95131
U.S.A.