1056265
Biomedix Wai — FEI 1000115518
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 8, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Chanhassen, MN (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3119 | 21 CFR 820.75(b) | Lack/Inad procedure-Monitoring/Control of Validated Proces |
| 3226 | 21 CFR 820.70(g)(1) | Maintenance schedule, Lack of or inadequate schedule |
| 3263 | 21 CFR 820.250(b) | Sampling plans |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |
| 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 |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |