536918
Philips Medical Systems (Cleveland) Inc — FEI 1525965
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 30, 2008
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Cleveland, OH (United States)
Citations
| ID | CFR | Description |
|---|
| 2431 | 21 CFR 820.30(b) | Design plans- updated |
| 2650 | 21 CFR 820.30(f) | Design verification - Lack of or inadequate procedures |
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3156 | 21 CFR 820.181(b) | DMR production process specifications |
| 3369 | 21 CFR 820.198(a)(1) | Uniform and timely processing |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4212 | 21 CFR 806.20(b)(4) | Justification for not reporting |