FDA Inspection
SpineMatrix IncSpineMatrix Inc – FDA Inspection, Aug 27, 2009
Record Details
This FDA Inspection record concerns SpineMatrix Inc, with an inspection on August 27, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- SpineMatrix Inc
- Inspection Date
- August 27, 2009
- Product Type
- Devices
View Company Profile
ID · 8e9a3352-f8c7-4f91-92a3-977f92d1f2ae
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 598579
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.198(a)General
- 21 CFR 820.198(a)Complete files maintained
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.170(a)Lack of or inadequate instructions
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
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Other FDA inspections of SpineMatrix Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 7, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for SpineMatrix Inc
- FDA Inspection 661569 - 2010-05-07
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