FDA Inspection 771411 — Olympus Winter & Ibe GmbH
The FDA completed an inspection of Olympus Winter & Ibe GmbH on January 19, 2012 in Teltow. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 19, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Teltow (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |