FDA Inspection 802743 — Usine Rotec Inc
The FDA completed an inspection of Usine Rotec Inc on August 30, 2012 in Baie-du-febvre. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 30, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Baie-du-febvre (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 2628 | 21 CFR 820.30(e) | Design review procedures - personnel |
| 2648 | 21 CFR 820.30(f) | Design verification procedures |
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3332 | 21 CFR 820.184(e) | ID label, labeling |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 4189 | 21 CFR 820.198(a) | General |