1149249
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- August 13, 2021
- Fiscal Year
- 2021
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Castleton On Hudson, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |