ORIGIN MEDICAL DEVICES HUNGARY KFT FDA Record
ORIGIN MEDICAL DEVICES HUNGARY KFT has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "ORIGIN MEDICAL DEVICES HUNGARY KFT" is on file.
- Latest inspection
- May 8, 2025 · NAI
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 | 1 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| May 8, 2025 | Vac, Hungary | Devices | No Action Indicated (NAI) | 3029922922 |
- 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 3029922922 | Vac, Hungary | 1 | May 8, 2025 |
ORIGIN MEDICAL DEVICES HUNGARY KFT and the FDA: common questions
Has ORIGIN MEDICAL DEVICES HUNGARY KFT received an FDA warning letter?
No FDA warning letter addressed to the name "ORIGIN MEDICAL DEVICES HUNGARY KFT" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has ORIGIN MEDICAL DEVICES HUNGARY KFT received an FDA Form 483?
FDA has not published a Form 483 for "ORIGIN MEDICAL DEVICES HUNGARY KFT" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect ORIGIN MEDICAL DEVICES HUNGARY KFT?
The most recent FDA inspection on file ended May 8, 2025 at Vac, Hungary and was classified NAI. FDA has 1 inspection of ORIGIN MEDICAL DEVICES HUNGARY KFT on file.
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