FDA Inspection
Eizo GmbHEizo GmbH – FDA Inspection, Sep 20, 2018
Record Details
This FDA Inspection record concerns Eizo GmbH, with an inspection on September 20, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b2657542-6120-4376-ada4-76673d50c58d
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1066467
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.120(b)DHR documentation of label release {see also 820.184}
- 21 CFR 820.198(b)Rationale documented for no investigation
- 21 CFR 820.200(d)Service reports
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
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Other FDA inspections of Eizo GmbH
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 5, 2026 | Not classified | Office of Inspections and Investigations | |
| January 20, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 22, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 28, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Eizo GmbH
- FDA Inspection 1312094 - 2026-03-05
- FDA Inspection 1196945 - 2023-01-20
- FDA Inspection 895411 - 2014-08-22
- FDA Inspection 779687 - 2012-03-28
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