1261187
Lingraphicare America, Inc. — FEI 1000123978
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 3, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Princeton, NJ (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2604 | 21 CFR 820.30(e) | Design review - Lack of or inadequate procedures |
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3199 | 21 CFR 820.40(a) | Document review, approval documentation |
| 633 | 21 CFR 803.17(a)(3) | Lack of System for Timely Submission of Reports |