994697
3T Medical Systems, LLC — FEI 3003261020
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 31, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Edison, NJ (United States)
Citations
| ID | CFR | Description |
|---|
| 14719 | 21 CFR 820.30(h) | Incorrect translation to production specifications |
| 2630 | 21 CFR 820.30(e) | Design review - documentation |
| 3102 | 21 CFR 820.30(h) | Design transfer - Lack of or inadequate procedures |
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |