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FDA establishment 3002807605, Bunkyo, Japan. Part of Mikasa X-Ray Co., Ltd.'s FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 2
Official action indicated: 0
Last inspection ended: Jun 5, 2025
Warning letters: 0
Inspections by Fiscal Year
FY2018 to FY2027 to date; 0 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 820.40(b). Document change records, maintained. Records of changes to documents were not maintained.
21 CFR 820.100(b). Documentation Corrective and preventive action activities and/or results have not been documented.
Voluntary Action Indicated (VAI)
Mar 10, 2017
Devices · Compliance: DevicesDevices · Radiation Control and Health Safety Act; Devices · Postmarket Assurance: Devices
5 cited references
21 CFR 820.70(c). Environmental control Lack of or inadequate procedures Procedures to control environmental conditions have not been adequately established.
21 CFR 820.70(i). Software validation for automated processes Software used as part of the quality system has not been adequately validated for its intended use according to an established protocol.
21 CFR 803.17. Lack of Written MDR Procedures Written MDR procedures have not been developed and maintained.
21 CFR 820.25(b). Training - Lack of or inadequate procedures Procedures for training and identifying training needs have not been adequately established.
21 CFR 820.80(a). Lack of or inadequate procedures - Acceptance activities Procedures for acceptance activities have not been 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. 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
Bunkyo, Japan. Part of