FDA Inspection 760439 — Mectron SPA
The FDA completed an inspection of Mectron SPA on December 1, 2011 in Carasco. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 1, 2011
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Carasco (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 3262 | 21 CFR 820.250(a) | Statistical techniques - Lack of or inadequate procedures |
| 3409 | 21 CFR 820.200(d) | Service reports |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4437 | 21 CFR 803.40(b) | Report of malfunction likely to cause death or injury |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |