Company
SwedenKitron AB, Jonkoping, Sweden – FDA Inspections
Inspection records and compliance data for Kitron AB in Jonkoping. 2 FDA inspections on record (1 OAI), 1 Form 483, last inspected November 10, 2022.
Company Profile
This profile covers Kitron AB based in Jonkoping, Sweden.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 1
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected December 13, 2018. Last inspected November 10, 2022.
Most cited issue areas
- Lack of or inadequate complaint procedures2 inspections
- Lack of or inadequate process validation2 inspections
- Purchasing controls, Lack of or inadequate procedures2 inspections
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 10, 2022 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1192014 |
| December 13, 2018 | OAI | Medical Devices & Rad Health · Compliance: Devices | 1074723 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Kitron AB
FEI Number
3009834076
Address
Mobelvagen 5, Jonkoping, Sweden
Country
Sweden
ID: 647d205a-5fcf-4f53-990f-473be4f4c4c2