Company
ItalyGambro Dasco SPA Monitors Division, Medolla, Italy – FDA Inspections
Inspection records and compliance data for Gambro Dasco SPA Monitors Division in Medolla. 4 FDA inspections on record (1 OAI), last inspected July 16, 2026.
Company Profile
This profile covers Gambro Dasco SPA Monitors Division based in Medolla, Italy.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 1
- VAI
- 1
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected February 12, 2009. Last inspected July 16, 2026.
Most cited issue areas
- Lack/Inad procedure-Monitoring/Control of Validated Proces1 inspection
- Lack of or inadequate procedures1 inspection
- Lack of or inadequate process validation1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 16, 2026 | Not classified | Medical Devices & Rad Health | 1328660 |
| April 3, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 923510 |
| May 6, 2010 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 667126 |
| February 12, 2009 | OAI | Medical Devices & Rad Health · Compliance: Devices | 568943 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Gambro Dasco SPA Monitors Division
FEI Number
3002807196
Address
Via Modenese 66, Medolla, Italy
Country
Italy
ID: c91ab0d4-a234-4992-9b71-b53de8faab70