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FDA establishment 3002808148, Nishishirakawa-Gun, Japan. Part of Shirakawa Olympus Co., Ltd.'s FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations and its recalls since 2016.
Inspections: 4
Official action indicated: 1
Last inspection ended: Nov 14, 2025
Warning letters: 0
Recalls since 2016: 1
Import refusals 2014 to 2023: 8, first Dec 9, 2015
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(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.
21 CFR 820.30(g). Design Validation - Risk analysis not performed/inadequate Risk analysis is incomplete.
21 CFR 820.50. Purchasing controls, Lack of or inadequate procedures Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established.
21 CFR 820.80(b). Lack of or inadequate receiving acceptance procedures Procedures for acceptance of incoming product have not been adequately established.
21 CFR 820.198(c). Investigation of device failures Complaints involving the possible failure of a device to meet any of its specifications were not where necessary.
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. Recalls come from FDA's enforcement reports (iRES), one row per recall even when it covers many lots. 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, warning letters and enforcement reports
Nishishirakawa-Gun, Japan. Part of