1028477
Space Maintainers Lab — FEI 2082148
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 10, 2017
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Chatsworth, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3668 | 21 CFR 820.20(c) | Management review dates |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |