Puracon GmbH FDA Record
- Latest inspection VAI · Feb 26, 2026
- No warning letters matched by name
Puracon GmbH has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Puracon GmbH" is on file.
- Latest inspection
- Feb 26, 2026 · VAI
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 | 2 | 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 |
|---|---|---|---|---|
| Feb 26, 2026 | Rosenheim, Germany | Devices | Voluntary Action Indicated (VAI) | 3004638532 |
| Aug 7, 2014 | Rosenheim, Germany | Devices | No Action Indicated (NAI) | 3004638532 |
- 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 3004638532 | Rosenheim, Germany | 2 | Feb 26, 2026 |
Puracon GmbH and the FDA: common questions
Has Puracon GmbH received an FDA warning letter?
No FDA warning letter addressed to the name "Puracon 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 Puracon GmbH received an FDA Form 483?
FDA has not published a Form 483 for "Puracon GmbH" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Puracon GmbH?
The most recent FDA inspection on file ended Feb 26, 2026 at Rosenheim, Germany and was classified VAI. FDA has 2 inspections of Puracon GmbH on file.
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