Ursapharm Arzneimittel GmbH FDA Record
Ursapharm Arzneimittel GmbH has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Ursapharm Arzneimittel GmbH" is on file.
- Latest inspection
- Oct 31, 2024 · VAI
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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 | 3 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Oct 31, 2024 | Saarbrucken, Germany | Drugs | Voluntary Action Indicated (VAI) | 3004978466 |
| Sep 25, 2015 | Saarbrucken, Germany | Drugs | No Action Indicated (NAI) | 3004978466 |
| Sep 13, 2013 | Saarbrucken, Germany | Drugs | Voluntary Action Indicated (VAI) | 3004978466 |
- 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 3004978466 | Saarbrucken, Germany | 3 | Oct 31, 2024 |
Ursapharm Arzneimittel GmbH and the FDA: common questions
Has Ursapharm Arzneimittel GmbH received an FDA warning letter?
No FDA warning letter addressed to the name "Ursapharm Arzneimittel 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 Ursapharm Arzneimittel GmbH received an FDA Form 483?
FDA has not published a Form 483 for "Ursapharm Arzneimittel GmbH" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Ursapharm Arzneimittel GmbH?
The most recent FDA inspection on file ended Oct 31, 2024 at Saarbrucken, Germany and was classified VAI. FDA has 3 inspections of Ursapharm Arzneimittel GmbH on file.
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