FDA Inspection
Eizo GmbHEizo GmbH – FDA Inspection, Mar 28, 2012
Record Details
This FDA Inspection record concerns Eizo GmbH, with an inspection on March 28, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Eizo GmbH
- Inspection Date
- March 28, 2012
- Product Type
- Devices
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ID · b3b048ed-28f0-401a-8515-040eb1dde590
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 779687
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.30(b)Design plans- updated
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 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 |
| September 20, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 22, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Eizo GmbH
- FDA Inspection 1312094 - 2026-03-05
- FDA Inspection 1196945 - 2023-01-20
- FDA Inspection 1066467 - 2018-09-20
- FDA Inspection 895411 - 2014-08-22
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