Safersonic Medizinprodukte Handelsges MBH FDA Record
- Latest inspection OAI · Mar 22, 2023
- No warning letters matched by name
Safersonic Medizinprodukte Handelsges MBH has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Safersonic Medizinprodukte Handelsges MBH" is on file.
- Latest inspection
- Mar 22, 2023 · OAI
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 |
|---|---|---|---|---|
| Mar 22, 2023 | Persenbeug-Gottsdorf, Austria | Devices | Official Action Indicated (OAI) | 3008177921 |
- 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 3008177921 | Persenbeug-Gottsdorf, Austria | 1 | Mar 22, 2023 |
Safersonic Medizinprodukte Handelsges MBH and the FDA: common questions
Has Safersonic Medizinprodukte Handelsges MBH received an FDA warning letter?
No FDA warning letter addressed to the name "Safersonic Medizinprodukte Handelsges MBH" 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 Safersonic Medizinprodukte Handelsges MBH received an FDA Form 483?
FDA has not published a Form 483 for "Safersonic Medizinprodukte Handelsges MBH" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Safersonic Medizinprodukte Handelsges MBH?
The most recent FDA inspection on file ended Mar 22, 2023 at Persenbeug-Gottsdorf, Austria and was classified OAI. FDA has 1 inspection of Safersonic Medizinprodukte Handelsges MBH on file, 1 of them classified OAI (official action indicated).
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