FDA Inspection 675579 — Oculus Optikgeraete GMBH
The FDA completed an inspection of Oculus Optikgeraete GMBH on Jun 24, 2010 in Wetzlar. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 24, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Wetzlar (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 454 | 21 CFR 820.40(a) | Document review, approval by designated individual |