FDA Inspection 747430 — Elcam Medical Italy SPA
The FDA completed an inspection of Elcam Medical Italy SPA on September 22, 2011 in Carpi. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 22, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Carpi (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3671 | 21 CFR 820.25(a) | Personnel |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |