FDA Inspection
Artsana S.p.A.Artsana S.p.A. – FDA Inspection, Jan 27, 2011
Record Details
This FDA Inspection record concerns Artsana S.p.A., with an inspection on January 27, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Artsana S.p.A.
- Inspection Date
- January 27, 2011
- Product Type
- Devices
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ID · d453cdde-90d0-4fa2-b43c-a3603fcf211b
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 717756
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.20(a)Management ensuring quality policy is understood
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(i)Documentation of software validation
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Artsana S.p.A.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 20, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 9, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Artsana S.p.A.
- FDA Inspection 1020927 - 2017-07-20
- FDA Inspection 834446 - 2013-05-09
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