1175173
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 15, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Garden City, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2557 | 21 CFR 820.30(c) | Design input - documentation |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |