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Olympus Medical Systems Corporation Warning Letter Details

Warning Letter

Olympus Medical Systems Corporation

2951 Ishikawa-machi Hachioji-shi , Tokyo 192-8507 Japan, (b)(6)@olympus.com

Issue DateOctober 07, 2026

FEI Number3002807795

Violations13

CountryJapan

Issuing Office

Center for Devices and Radiological Health

Product Type

Medical Devices

Status

Open

Subject

CGMP/QSR/Medical Devices/Adulterated

Olympus Medical Systems Corporation FDA Warning Letter, October 7, 2026