FDA Inspection
Unomedical A/SUnomedical A/S – FDA Inspection, Oct 30, 2014
Record Details
This FDA Inspection record concerns Unomedical A/S, with an inspection on October 30, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Unomedical A/S
- Inspection Date
- October 30, 2014
- Product Type
- Devices
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ID · 7949ea4c-07cc-4be4-b1fe-b9d42f8d2e31
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 903722
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.100(b)Documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation - production units
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Other FDA inspections of Unomedical A/S
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 24, 2024 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 28, 2018 | Not classified | Office of Inspections and Investigations | Postmarket Assurance: Devices |
Other documents for Unomedical A/S
- FDA Inspection 1241138 - 2024-05-24
- FDA Inspection 1043245 - 2018-02-28
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