Dornier Medtech GmbH FDA Record
- Latest inspection NAI · Dec 14, 2022
- Last warning letter 2011
Dornier Medtech GmbH has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Dornier Medtech GmbH, the most recent on Aug 26, 2011.
- Latest inspection
- Dec 14, 2022 · 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 | 2 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Dornier Medtech GmbH FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Aug 26, 2011 · Record page |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Dec 14, 2022 | Wessling, Germany | Devices | No Action Indicated (NAI) | 3002806833 |
| Apr 29, 2011 | Wessling, Germany | Devices | Official Action Indicated (OAI) | 3002806833 |
- 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.
Compliance Actions
FDA's compliance actions data lists 1 compliance action under Dornier Medtech GmbH: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3002806833 | Wessling, Germany | 2 | Dec 14, 2022 |
Dornier Medtech GmbH and the FDA: common questions
Has Dornier Medtech GmbH received an FDA warning letter?
Yes. FDA has issued 1 warning letter to Dornier Medtech GmbH. The most recent is dated Aug 26, 2011.
Has Dornier Medtech GmbH received an FDA Form 483?
FDA has not published a Form 483 for "Dornier Medtech GmbH" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Dornier Medtech GmbH?
The most recent FDA inspection on file ended Dec 14, 2022 at Wessling, Germany and was classified NAI. FDA has 2 inspections of Dornier Medtech GmbH on file, 1 of them classified OAI (official action indicated).
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