1148884
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- August 16, 2021
- Fiscal Year
- 2021
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Lancaster, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3837 | 21 CFR 820.25(b) | Training records |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |