FDA Inspection 1055546 — Labotect Labor-Technik Gottingen GmbH
The FDA completed an inspection of Labotect Labor-Technik Gottingen GmbH on Jun 14, 2018 in Rosdorf. 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). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 14, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Rosdorf (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3159 | 21 CFR 820.184 | DHR content |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |