Company
HungaryColoplast Hungary Kft, Tatabanya, Hungary – FDA Inspections
Inspection records and compliance data for Coloplast Hungary Kft in Tatabanya. 2 FDA inspections on record, last inspected June 11, 2015.
Company Profile
This profile covers Coloplast Hungary Kft based in Tatabanya, Hungary.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected June 18, 2009. Last inspected June 11, 2015.
Most cited issue areas
- Documentation1 inspection
- Documentation of software validation1 inspection
- Nonconforming product, Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 11, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 934134 |
| June 18, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 599050 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Coloplast Hungary Kft
FEI Number
3003814961
Address
Buzaviraq Ut 15, Tatabanya, Hungary
Country
Hungary
ID: ca32dfbc-ceb4-4a6f-bad8-7af0a7859657