Mt. Derm GmbH FDA Record
- Latest inspection VAI · Jan 26, 2023
- No warning letters matched by name
Mt. Derm GmbH has 0 FDA recalls, 1 inspection, 3 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Mt. Derm GmbH" is on file.
- Latest inspection
- Jan 26, 2023 · VAI
- Latest 510(k)
- Feb 23, 2024
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 | 3 | 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 |
|---|---|---|---|---|
| Jan 26, 2023 | Berlin, Germany | Devices | Voluntary Action Indicated (VAI) | 3006634874 |
- 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 3006634874 | Berlin, Germany | 1 | Jan 26, 2023 |
Mt. Derm GmbH and the FDA: common questions
Has Mt. Derm GmbH received an FDA warning letter?
No FDA warning letter addressed to the name "Mt. Derm GmbH" 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 Mt. Derm GmbH received an FDA Form 483?
FDA has not published a Form 483 for "Mt. Derm GmbH" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Mt. Derm GmbH?
The most recent FDA inspection on file ended Jan 26, 2023 at Berlin, Germany and was classified VAI. FDA has 1 inspection of Mt. Derm GmbH on file.
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