FDA Inspection 906898 — Leonhard Lang GmbH
The FDA completed an inspection of Leonhard Lang GmbH on Nov 20, 2014 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 20, 2014
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Innsbruck (Austria)
Citations
| ID | CFR | Description |
|---|---|---|
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 2431 | 21 CFR 820.30(b) | Design plans- updated |
| 2604 | 21 CFR 820.30(e) | Design review - Lack of or inadequate procedures |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |