Company
ItalyArtsana S.p.A., Casnate Con Bernate, Italy – FDA Inspections
Inspection records and compliance data for Artsana S.p.A. in Casnate Con Bernate. 3 FDA inspections on record (1 OAI), 1 Form 483, last inspected July 20, 2017.
Company Profile
This profile covers Artsana S.p.A. based in Casnate Con Bernate, Italy.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 1
- VAI
- 1
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected January 27, 2011. Last inspected July 20, 2017.
Most cited issue areas
- Documentation of software validation1 inspection
- Lack of or inadequate complaint procedures1 inspection
- Lack of or inadequate process validation1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 20, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1020927 |
| May 9, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 834446 |
| January 27, 2011 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 717756 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Artsana S.p.A.
FEI Number
3002807528
Address
Via Filomena Saldarini Catelli 6/10, Casnate Con Bernate, Italy
Country
Italy
ID: 2bb6d806-2a76-4eae-b285-313b572ea6af