1155070
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 22, 2021
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Monument, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |