FDA Inspection 778367 — RI.MOS.SRL
The FDA completed an inspection of RI.MOS.SRL on March 29, 2012 in Mirandola. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 29, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Mirandola (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 3111 | 21 CFR 820.70(f) | Buildings |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3236 | 21 CFR 820.72(b) | Calibration procedures - content |
| 3269 | 21 CFR 820.80(b) | Incoming acceptance records, documentation |
| 3312 | 21 CFR 820.120(d) | Mixups |
| 3671 | 21 CFR 820.25(a) | Personnel |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |