1276815
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 28, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Morgantown, WV (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 4191 | 21 CFR 806.10(a)(1) | Report of risk to health |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |