Company
GermanyMetasystems Gmbh, Altlusheim, Germany – FDA Inspections
Inspection records and compliance data for Metasystems Gmbh in Altlusheim. 2 FDA inspections on record, last inspected November 17, 2016.
Company Profile
This profile covers Metasystems Gmbh based in Altlusheim, Germany.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected June 27, 2013. Last inspected November 17, 2016.
Most cited issue areas
- Design transfer - Lack of or inadequate procedures1 inspection
- Design validation - software validation not performed1 inspection
- Software validation for automated processes1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 17, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 998269 |
| June 27, 2013 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 839604 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Metasystems Gmbh
FEI Number
3003342560
Address
Robert-Bosch-Str. 6, Altlusheim, Germany
Country
Germany
ID: e844b43f-bd43-4561-a745-85b2b00a9b39