Company
HungaryColoplast Hungary, KFT., Nyirbator, Hungary – FDA Inspections
Inspection records and compliance data for Coloplast Hungary, KFT. in Nyirbator. 3 FDA inspections on record (1 OAI), 1 Form 483, last inspected September 01, 2017.
Company Profile
This profile covers Coloplast Hungary, KFT. based in Nyirbator, Hungary.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 1
- VAI
- 0
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected June 25, 2009. Last inspected September 1, 2017.
Most cited issue areas
- DHR content1 inspection
- Investigation of device failures1 inspection
- Lack of or inadequate final acceptance procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 1, 2017 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1024793 |
| March 4, 2014 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 868322 |
| June 25, 2009 | OAI | Medical Devices & Rad Health · Compliance: Devices | 607321 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Coloplast Hungary, KFT.
FEI Number
3006606901
Address
Coloplast Ut 2, Nyirbator, Hungary
Country
Hungary
ID: cc7e69ef-1602-495c-9cde-ab007815919b