1209554
Zuga Medical Inc. — FEI 3010251542
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- June 26, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Chagrin Falls, OH (United States)
Citations
| ID | CFR | Description |
|---|
| 3102 | 21 CFR 820.30(h) | Design transfer - Lack of or inadequate procedures |
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3173 | 21 CFR 820.198(d) | Evaluation, timeliness, identification |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |