FDA Inspection
Unitron Group BvUnitron Group Bv – FDA Inspection, Sep 13, 2018
Record Details
This FDA Inspection record concerns Unitron Group Bv, with an inspection on September 13, 2018, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 49ec331e-06dc-4315-9cf3-f91547e26fd6
Inspection Facts
- Inspection number
- 1065439
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
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Other FDA inspections of Unitron Group Bv
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 6, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Unitron Group Bv
- FDA Inspection 906057 - 2014-11-06
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