FDA Inspection
Nikomed USA, IncNikomed USA, Inc – FDA Inspection, Feb 6, 2017
Record Details
This FDA Inspection record concerns Nikomed USA, Inc, with an inspection on February 6, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ca632cf4-af07-422f-a772-03c2b1e4d3bc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1000189
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(b)Documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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Other FDA inspections of Nikomed USA, Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 1, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 9, 2008 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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