1242297
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 26, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Louisville, KY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 22795 | 21 CFR 801.20(a) | Label to bear a unique device identifier |
| 22800 | 21 CFR 830.300(a) | Devices subject to device identification GUDID data submission requirements. |