Company
NetherlandsUnitron Group Bv, Ijzendijke, Netherlands – FDA Inspections
Inspection records and compliance data for Unitron Group Bv in Ijzendijke. 2 FDA inspections on record, 1 Form 483, last inspected September 13, 2018.
Company Profile
This profile covers Unitron Group Bv based in Ijzendijke, Netherlands.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected November 6, 2014. Last inspected September 13, 2018.
Most cited issue areas
- Design input - Lack of or inadequate procedures1 inspection
- Design validation- Lack of or inadequate procedures1 inspection
- Environmental control Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 13, 2018 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1065439 |
| November 6, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 906057 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Unitron Group Bv
FEI Number
3008388260
Address
Schansestraat 7, Ijzendijke, Netherlands
Country
Netherlands
ID: d1633585-bd82-4376-9f26-dca724a6338a