Olympus Corporation of the Americas

WARNING LETTER
AUG 12, 2015

VIA UNITED PARCEL SERVICE

Akihiro Okubo, President
Olympus Medical Systems Corporation
2951 Ishikawa-cho, Hachioji-shi
Tokyo 192-8507, Japan

Dear Mr. Okubo:

The United States Food and Drug Administration (FDA) conducted inspections at your following facilities:
Olympus Medical Systems Corporation, located at 2951 Ishikawa-cho, Hachioji-shi, Tokyo 192-8507, Japan, on April 20, 2015 through April 24, 2015;

– Aizu Olympus Co., Ltd., located at 500 Aza Muranishi Ooaza, Niidera, Monden-Machi, Aizuwakamatsu-shi, Fukushima 965-8520, Japan, on April 13, 2015 through April 17, 2015;
– Olympus Corporation of the Americas, located at 3500 Corporate Parkway, Center Valley, Pennsylvania 18034, U.S.A., on March 25, 2015 through April 1, 2015; and
– Olympus Corporation of the Americas, located at 2400 Ringwood Avenue, San Jose, California 95131, U.S.A., on March 19, 2015 through April 2, 2015.

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Last Updated: 2016-03-09

Olympus Corporation of the Americas