1228838
Omega Laboratories Inc — FEI 3004847291
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 8, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Mogadore, OH (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |