1289290
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 30, 2025
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Bethesda, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3104 | 21 CFR 820.30(j) | Design history file |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |