Company
ItalyQuanta System SpA, Solbiate Olona, Italy – FDA Inspections
Inspection records and compliance data for Quanta System SpA in Solbiate Olona. 2 FDA inspections on record (1 OAI), 1 Form 483, last inspected December 01, 2017.
Company Profile
This profile covers Quanta System SpA based in Solbiate Olona, Italy.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 1
- VAI
- 0
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected April 19, 2012. Last inspected December 1, 2017.
Most cited issue areas
- Analyzing service report1 inspection
- Design control - no procedures1 inspection
- DHR documentation of label release {see also 820.184}1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 1, 2017 | Not classified | Medical Devices & Rad Health | 1042506 |
| April 19, 2012 | OAI | Medical Devices & Rad Health · Compliance: Devices | 780939 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Quanta System SpA
FEI Number
3004378299
Address
Via Quattro Novembre 116, Solbiate Olona, Italy
Country
Italy
ID: fa03e3d6-9feb-470e-8e7e-2d96bad2c902