FDA Inspection 1136920 — BSN Medical Inc
The FDA completed an inspection of BSN Medical Inc on Mar 22, 2021 in Charlotte, NC. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Mar 22, 2021
- Fiscal Year
- 2021
- Product Type
- Devices
- Project Area
- Postmarket Assurance: 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 |