Company
BelgiumFujirebio Europe N.V., Gent, Belgium – FDA Inspections
Inspection records and compliance data for Fujirebio Europe N.V. in Gent. 2 FDA inspections on record, 1 Form 483, last inspected June 06, 2019.
Company Profile
This profile covers Fujirebio Europe N.V. based in Gent, Belgium.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 0
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected November 10, 2016. Last inspected June 6, 2019.
Most cited issue areas
- Design validation - software validation not performed1 inspection
- Lack of or inadequate complaint procedures1 inspection
- Nonconforming product, Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 6, 2019 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1096452 |
| November 10, 2016 | Not classified | Medical Devices & Rad Health · Project Evaluation: Devices | 992892 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Fujirebio Europe N.V.
FEI Number
3002608770
Address
Technologiepark-Zwijnaarde 6, Gent, Belgium
Country
Belgium
ID: 996335ef-584f-4ca6-b05c-928c179aa8fe