1216005
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- August 25, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Durham, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 4057 | 21 CFR 820.20(a) | Management ensuring quality policy is understood |