FDA Inspection 839604 — Metasystems Gmbh
The FDA completed an inspection of Metasystems Gmbh on Jun 27, 2013 in Altlusheim. 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
- Jun 27, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Altlusheim (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 3102 | 21 CFR 820.30(h) | Design transfer - Lack of or inadequate procedures |
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3677 | 21 CFR 820.30(g) | Design validation - software validation not performed |