FDA Inspection
Metasystems GmbhMetasystems Gmbh – FDA Inspection, Jun 27, 2013
Record Details
This FDA Inspection record concerns Metasystems Gmbh, with an inspection on June 27, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Metasystems Gmbh
- Inspection Date
- June 27, 2013
- Product Type
- Devices
View Company Profile
ID · a3e94bb2-d139-4505-92cc-bcfa74ed6630
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 839604
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 820.30(g)Design validation - software validation not performed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Metasystems Gmbh
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 17, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Metasystems Gmbh
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.