FDA Inspection 568943 — Gambro Dasco SPA Monitors Division
The FDA completed an inspection of Gambro Dasco SPA Monitors Division on Feb 12, 2009 in Medolla. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Feb 12, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Medolla (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 3119 | 21 CFR 820.75(b) | Lack/Inad procedure-Monitoring/Control of Validated Proces |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |