987330
First Source Inc — FEI 3004063527
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 10, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Rochester, NY (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |