737706
Penlon Limited — FEI 3002807907
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 28, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Abingdon (United Kingdom)
Citations
| ID | CFR | Description |
|---|
| 14718 | 21 CFR 820.30(g) | Design validation - Risk analysis |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3155 | 21 CFR 820.181(a) | DMR device specifications |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3345 | 21 CFR 820.200(a) | Servicing - Lack of or inadequate procedures |
| 3674 | 21 CFR 820.30(d) | Design output - documentation |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |