817590
Biomerieux Inc — FEI 1950204
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 5, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Hazelwood, MO (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3677 | 21 CFR 820.30(g) | Design validation - software validation not performed |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |