Company
GermanyInstitut Virion/Serion Gmbh, Wurzburg, Germany – FDA Inspections
Inspection records and compliance data for Institut Virion/Serion Gmbh in Wurzburg. 1 FDA inspection on record, 1 Form 483, last inspected September 13, 2018.
Company Profile
This profile covers Institut Virion/Serion Gmbh based in Wurzburg, Germany.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 0
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
Inspected September 13, 2018.
Most cited issue areas
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
- Design validation- Lack of or inadequate procedures1 inspection
- Lack of or inadequate process validation1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 13, 2018 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1065778 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Institut Virion/Serion Gmbh
FEI Number
3010194607
Address
Friedrich-Bergius-Ring 19, Wurzburg, Germany
Country
Germany
ID: 6e66fac7-c21b-4e06-9fd7-5ce053b76a48