FDA Inspection
MiE medical imaging electronics GmbHMiE medical imaging electronics GmbH – FDA Inspection, Oct 12, 2023
Record Details
This FDA Inspection record concerns MiE medical imaging electronics GmbH, with an inspection on October 12, 2023, issued by the Office of Inspections and Investigations.
- Inspection Date
- October 12, 2023
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ID · 884fd96d-db87-43f2-ad45-8592f2c96b82
Inspection Facts
- Inspection number
- 1220602
- FDA center
- Medical Devices & Rad Health
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.120(b)Labeling inspection - UDI
- 21 CFR 820.30(g)Design validation - documentation
- 21 CFR 820.50(a)(1)Documented evaluation
- 21 CFR 820.50(b)Supplier notification of changes
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Other FDA inspections of MiE medical imaging electronics GmbH
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 31, 2018 | Not classified | Office of Inspections and Investigations | Radiation Control and Health Safety Act |
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