1101333
Reprobiotech Corp — FEI 3015534920
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 5, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Flushing, NY (United States)
Citations
| ID | CFR | Description |
|---|
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 3206 | 21 CFR 820.50(b) | Approval, inadequate purchasing data |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |