FDA Inspection 1002852 — Olympus Winter & IBE Gmbh
The FDA completed an inspection of Olympus Winter & IBE Gmbh on Jan 26, 2017 in Hamburg. 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 26, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Hamburg (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 733 | 21 CFR 803.50(b)(1) | Reporting Information Reasonably Known |