1070662
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- November 6, 2018
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Erie, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |