FDA Inspection
Cablon Medical B.V.Cablon Medical B.V. – FDA Inspection, Jul 21, 2011
Record Details
This FDA Inspection record concerns Cablon Medical B.V., with an inspection on July 21, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Cablon Medical B.V.
- Inspection Date
- July 21, 2011
- Product Type
- Devices
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ID · 10d3577c-85ed-482b-b751-038c4039e2c7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 737692
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.30(d)Design output - documentation
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.70(i)Documentation of software validation
- 21 CFR 820.50(b)Supplier notification of changes
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Other FDA inspections of Cablon Medical B.V.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 15, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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