Company
HungaryCelitron Medical Technologies Kft, Vac, Hungary – FDA Inspections
Inspection records and compliance data for Celitron Medical Technologies Kft in Vac. 2 FDA inspections on record, last inspected December 21, 2017.
Company Profile
This profile covers Celitron Medical Technologies Kft based in Vac, Hungary.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected November 20, 2014. Last inspected December 21, 2017.
Most cited issue areas
- Design review - Lack of or inadequate procedures1 inspection
- Design verification - output does not meet input requirement1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 21, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1047795 |
| November 20, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 905857 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Celitron Medical Technologies Kft
FEI Number
3009775411
Address
Szent Laszlo ut 36, Vac, Hungary
Country
Hungary
ID: 93164e40-7572-4e78-aa57-35435cc12891