FDA Inspection 738886 — Osmed Gmbh
The FDA completed an inspection of Osmed Gmbh on Jul 28, 2011 in Ilmenau. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 2 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jul 28, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Ilmenau (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |