Company
ItalyAssut Europe S.p.A., Magliano De' Marsi, Italy – FDA Inspections
Inspection records and compliance data for Assut Europe S.p.A. in Magliano De' Marsi. 2 FDA inspections on record (1 OAI), 2 Form 483s, last inspected September 26, 2024.
Company Profile
This profile covers Assut Europe S.p.A. based in Magliano De' Marsi, Italy.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 1
- VAI
- 1
- NAI
- 0
- Form 483s
- 2
- Warning letters
- 0
First inspected January 11, 2018. Last inspected September 26, 2024.
Most cited issue areas
- Lack/Inad procedure-Monitoring/Control of Validated Proces1 inspection
- Lack of or inadequate complaint procedures1 inspection
- Lack of or inadequate final acceptance procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 26, 2024 | OAI | Medical Devices & Rad Health · Compliance: Medical Devices | 1244235 |
| January 11, 2018 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1040015 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Assut Europe S.p.A.
FEI Number
3003272809
Address
Zona Industriale, Nucleo Industriale Snc, Magliano De' Marsi, Italy
Country
Italy
ID: 60e875d5-ed63-4b93-9e60-dbd5964ea6e1