Company
ItalyIMS GIOTTO S.p.A., Sasso Marconi, Italy – FDA Inspections
Inspection records and compliance data for IMS GIOTTO S.p.A. in Sasso Marconi. 2 FDA inspections on record (1 OAI), last inspected December 04, 2014.
Company Profile
This profile covers IMS GIOTTO S.p.A. based in Sasso Marconi, Italy.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 1
- VAI
- 0
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected December 12, 2013. Last inspected December 4, 2014.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design validation- Lack of or inadequate procedures1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 4, 2014 | NAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 907150 |
| December 12, 2013 | OAI | Medical Devices & Rad Health · Compliance: Devices | 859900 |
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
IMS GIOTTO S.p.A.
FEI Number
3002807317
Address
Sasso Marconi , Via Sagittario 5, Sasso Marconi, Italy
Country
Italy
ID: c9669b6d-c8a4-4656-b49b-46401a92ce64