Company
HungaryMeditech KFT, Budapest, Hungary – FDA Inspections
Inspection records and compliance data for Meditech KFT in Budapest. 3 FDA inspections on record (1 OAI), 1 Form 483, last inspected June 28, 2018.
Company Profile
This profile covers Meditech KFT based in Budapest, Hungary.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 1
- VAI
- 2
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected April 13, 2012. Last inspected June 28, 2018.
Most cited issue areas
- Complaints1 inspection
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design review - Lack of or inadequate procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 28, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1057201 |
| January 15, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 921149 |
| April 13, 2012 | OAI | Medical Devices & Rad Health · Compliance: Devices | 779843 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Meditech KFT
FEI Number
3003764019
Address
Mikszath Kalman Utca 24, Budapest, Hungary
Country
Hungary
ID: b98981ca-fdfa-4ba9-a8cf-ae68e104157f