Vygon Us, LLC FDA Record
- Latest inspection NAI · Jun 26, 2009
- No warning letters matched by name
Vygon Us, LLC has 0 FDA recalls, 1 inspection, 4 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Vygon Us, LLC" is on file.
- Latest inspection
- Jun 26, 2009 · NAI
- Latest 510(k)
- Aug 12, 2008
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 | 4 | 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 |
|---|---|---|---|---|
| Jun 26, 2009 | Norristown, PA | Devices | No Action Indicated (NAI) | 2518608 |
- 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 2518608 | Norristown, PA | 1 | Jun 26, 2009 |
Vygon Us, LLC and the FDA: common questions
Has Vygon Us, LLC received an FDA warning letter?
No FDA warning letter addressed to the name "Vygon Us, LLC" 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 Vygon Us, LLC received an FDA Form 483?
FDA has not published a Form 483 for "Vygon Us, LLC" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Vygon Us, LLC?
The most recent FDA inspection on file ended Jun 26, 2009 at Norristown, PA and was classified NAI. FDA has 1 inspection of Vygon Us, LLC on file.
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