EUROIMMUN Medizinische Labordiagnostika AG FDA Record
- Latest inspection NAI · Jun 11, 2015
- No warning letters matched by name
EUROIMMUN Medizinische Labordiagnostika AG has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "EUROIMMUN Medizinische Labordiagnostika AG" is on file.
- Latest inspection
- Jun 11, 2015 · NAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 0 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 1 | Nov 15, 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 |
|---|---|---|---|---|
| Jun 11, 2015 | Lubeck, Germany | Devices | No Action Indicated (NAI) | 3003268355 |
- 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 3003268355 | Lubeck, Germany | 1 | Jun 11, 2015 |
EUROIMMUN Medizinische Labordiagnostika AG and the FDA: common questions
Has EUROIMMUN Medizinische Labordiagnostika AG received an FDA warning letter?
No FDA warning letter addressed to the name "EUROIMMUN Medizinische Labordiagnostika AG" 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 EUROIMMUN Medizinische Labordiagnostika AG received an FDA Form 483?
FDA has not published a Form 483 for "EUROIMMUN Medizinische Labordiagnostika AG" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect EUROIMMUN Medizinische Labordiagnostika AG?
The most recent FDA inspection on file ended Jun 11, 2015 at Lubeck, Germany and was classified NAI. FDA has 1 inspection of EUROIMMUN Medizinische Labordiagnostika AG on file.
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