FDA Inspection
Axon Systems IncAxon Systems Inc – FDA Inspection, Nov 10, 2009
Record Details
This FDA Inspection record concerns Axon Systems Inc, with an inspection on November 10, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Axon Systems Inc
- Inspection Date
- November 10, 2009
- Product Type
- Devices
View Company Profile
ID · a5e24dc1-2d52-4dde-a2fe-7d8c15aa1d66
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 628204
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.100(b)Documentation
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
- 21 CFR 820.30(g)Design validation - documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Axon Systems Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 4, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 2, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Axon Systems Inc
- FDA Inspection 821748 - 2013-03-04
- FDA Inspection 713499 - 2011-03-02
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