883463
Lingraphicare America, Inc. — FEI 1000123978
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 24, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Princeton, NJ (United States)
Citations
| ID | CFR | Description |
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3677 | 21 CFR 820.30(g) | Design validation - software validation not performed |