Coloplast Hungary Kft
Coloplast Hungary Kft has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Jun 11, 2015 · VAI
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 4 | Nov 13, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jun 11, 2015 | Tatabanya, Hungary | Devices | Voluntary Action Indicated (VAI) | 3003814961 |
| Mar 4, 2014 | Nyirbator, Hungary | Devices | No Action Indicated (NAI) | 3006606901 |
| Jun 25, 2009 | Nyirbator, Hungary | Devices | Official Action Indicated (OAI) | 3006606901 |
| Jun 18, 2009 | Tatabanya, Hungary | Devices | Voluntary Action Indicated (VAI) | 3003814961 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3003814961 | Tatabanya, Hungary | 2 | Jun 11, 2015 |
| FEI 3006606901 | Nyirbator, Hungary | 2 | Mar 4, 2014 |
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