FDA Inspection 771508 — Lasering S.r.l.
The FDA completed an inspection of Lasering S.r.l. on March 8, 2012 in Modena. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 8, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Modena (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 2604 | 21 CFR 820.30(e) | Design review - Lack of or inadequate procedures |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3203 | 21 CFR 820.40(b) | Document change records, maintained. |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |