1099521
Life Sensing Instruments, Inc. — FEI 1037137
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- August 14, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Charlotte, NC (United States)
Citations
| ID | CFR | Description |
|---|
| 14717 | 21 CFR 820.30(g) | Design validation - software validation documentation |
| 21424 | 21 CFR 820.120(b) | Labeling inspection - UDI |
| 3159 | 21 CFR 820.184 | DHR content |
| 3191 | 21 CFR 820.30(g) | Design validation - production units |
| 3676 | 21 CFR 820.30(f) | Design verification - documentation |
| 3686 | 21 CFR 820.90(b)(2) | Product rework documentation, DHR {see also 820.184} |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |