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FDA establishment 3003637092, Nishitama-Gun, Japan. Part of Olympus Medical Systems's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 4
Official action indicated: 2
Last inspection ended: Nov 21, 2025
Warning letters: 1
Inspections by Fiscal Year
FY2018 to FY2027 to date; 1 classified OAI
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
21 CFR 820.75(c). Process changes - review, evaluation and revalidation A validated process was not revalidated when changes or process deviations occurred.
21 CFR 820.90(a). Nonconforming product control Products that do not conform to specifications are not adequately controlled.
21 CFR 820.75(a). Lack of or inadequate process validation A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm.FDA Data Dashboard and warning letters
Nishitama-Gun, Japan. Part of