1146978
Kelyniam Global, Inc. — FEI 3009424796
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 22, 2021
- Fiscal Year
- 2021
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Collinsville, CT (United States)
Citations
| ID | CFR | Description |
|---|
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 2557 | 21 CFR 820.30(c) | Design input - documentation |
| 3159 | 21 CFR 820.184 | DHR content |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |