FDA Inspection
Angiologica B.M. S.r.l.Angiologica B.M. S.r.l. – FDA Inspection, Oct 25, 2012
Record Details
This FDA Inspection record concerns Angiologica B.M. S.r.l., with an inspection on October 25, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Angiologica B.M. S.r.l.
- Inspection Date
- October 25, 2012
- Product Type
- Devices
View Company Profile
ID · 6c901e16-d247-4519-8196-cbf8126f251f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 803995
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Angiologica B.M. S.r.l.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 25, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 16, 2009 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Angiologica B.M. S.r.l.
- FDA Inspection 945930 - 2015-09-25
- FDA Inspection 599811 - 2009-07-16
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