FDA Inspection 833997 — Ulrich Gmbh & Co. KG
The FDA completed an inspection of Ulrich Gmbh & Co. KG on May 3, 2013 in Ulm. 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
- May 3, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Ulm (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 14718 | 21 CFR 820.30(g) | Design validation - Risk analysis |
| 2630 | 21 CFR 820.30(e) | Design review - documentation |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3190 | 21 CFR 820.30(g) | Design validation acceptance criteria |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |