1182099
Synovo Production, Inc. — FEI 2280596
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 26, 2022
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Fullerton, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 3668 | 21 CFR 820.20(c) | Management review dates |
| 3837 | 21 CFR 820.25(b) | Training records |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |