1094963
Antarma LLC — FEI 3014117096
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 7, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- New York, NY (United States)
Citations
| ID | CFR | Description |
|---|
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 2557 | 21 CFR 820.30(c) | Design input - documentation |
| 2604 | 21 CFR 820.30(e) | Design review - Lack of or inadequate procedures |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3204 | 21 CFR 820.40(b) | Change records, content |
| 3206 | 21 CFR 820.50(b) | Approval, inadequate purchasing data |