1062796
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 21, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- New Brunswick, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |