FDA Inspection
MicroPort CRM S.r.l.MicroPort CRM S.r.l. – FDA Inspection, Mar 3, 2011
Record Details
This FDA Inspection record concerns MicroPort CRM S.r.l., with an inspection on March 3, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- MicroPort CRM S.r.l.
- Inspection Date
- March 3, 2011
- Product Type
- Devices
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ID · d6aa90ac-db1e-4253-9ce4-3f7f7b36e7b4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 715134
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate 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 MicroPort CRM S.r.l.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 28, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 2, 2009 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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