Laboratoires Urgo FDA Record
- Latest inspection NAI · Dec 14, 2017
- No warning letters matched by name
Laboratoires Urgo has 0 FDA recalls, 1 inspection, 8 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Laboratoires Urgo" is on file.
- Latest inspection
- Dec 14, 2017 · NAI
- Latest 510(k)
- Aug 7, 2015
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 | 8 | 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 |
|---|---|---|---|---|
| Dec 14, 2017 | Chevigny St Sauveur, France | Devices | No Action Indicated (NAI) | 3007671324 |
- 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 3007671324 | Chevigny St Sauveur, France | 1 | Dec 14, 2017 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K143017 | Urgoclean Ag, Antibacterial Absorbent Wound Dressing with Silver | Aug 7, 2015 |
| K123219 | URGOCLEAN ABSORBENT WOUND DRESSING | Mar 18, 2013 |
| K100429 | URGOCELL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER | Jun 11, 2010 |
| K100430 | URGOTUL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER | Jun 11, 2010 |
| K062559 | URGOCELL AG ANTIMICROBIAL WOUND DRESSING WITH SILVER | Jan 29, 2007 |
| K061220 | URGOTUL AG | Jul 27, 2006 |
| K974348 | ALGOPLAQUE FILM EXTRA THIN HYDROCOLLOID DRESSING | Feb 13, 1998 |
| K970518 | ALGOPLAQUE HYDROCOLLOID DRESSING | Mar 21, 1997 |
Laboratoires Urgo and the FDA: common questions
Has Laboratoires Urgo received an FDA warning letter?
No FDA warning letter addressed to the name "Laboratoires Urgo" 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 Laboratoires Urgo received an FDA Form 483?
FDA has not published a Form 483 for "Laboratoires Urgo" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Laboratoires Urgo?
The most recent FDA inspection on file ended Dec 14, 2017 at Chevigny St Sauveur, France and was classified NAI. FDA has 1 inspection of Laboratoires Urgo on file.
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