FDA Inspection 817588 — Rubimed AG
The FDA completed an inspection of Rubimed AG on Jan 29, 2013 in Hergiswil Nw. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 6 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jan 29, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Hergiswil Nw (Switzerland)
Citations
| ID | CFR | Description |
|---|---|---|
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |
| 4189 | 21 CFR 820.198(a) | General |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |