FDA Inspection 1097388 — Leonhard Lang GmbH
The FDA completed an inspection of Leonhard Lang GmbH on Jul 24, 2019 in Innsbruck. 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 24, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Project Evaluation: Devices
- Location
- Innsbruck (Austria)
Additional details
Postmarket Audit Inspections
Citations
| ID | CFR | Description |
|---|---|---|
| 3159 | 21 CFR 820.184 | DHR content |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |