1288356
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- October 22, 2025
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Cincinnati, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 22795 | 21 CFR 801.20(a) | Label to bear a unique device identifier |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3665 | 21 CFR 820.20(b)(3) | Management representative |
| 3696 | 21 CFR 820.100(b) | Documentation |