1136920
BSN Medical Inc — FEI 1038963
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 22, 2021
- Fiscal Year
- 2021
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Charlotte, NC (United States)
Citations
| ID | CFR | Description |
|---|
| 14714 | 21 CFR 820.30(c) | Design input - Lack of or inadequate procedures |
| 14715 | 21 CFR 820.30(d) | Design output - Lack of or inadequate procedures |
| 2430 | 21 CFR 820.30(b) | Design plans - Lack of or inadequate |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3191 | 21 CFR 820.30(g) | Design validation - production units |
| 3434 | 21 CFR 820.75(c) | Documentation - review in response to changes or deviations |