1242930
The Morel Company, LLC — FEI 3010388769
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 2, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Batesville, IN (United States)
Citations
| ID | CFR | Description |
|---|
| 3102 | 21 CFR 820.30(h) | Design transfer - Lack of or inadequate procedures |
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 3285 | 21 CFR 820.90(b)(2) | Product rework procedures, Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |