1274527
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- June 26, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Shelton, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 22800 | 21 CFR 830.300(a) | Devices subject to device identification GUDID data submission requirements. |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |