FDA Inspection 912828 — Barkey GmbH & Co. KG
The FDA completed an inspection of Barkey GmbH & Co. KG on Jan 22, 2015 in Leopoldshohe. 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 22, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Leopoldshohe (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |