Integra NeuroSciences Implants (France) S.A.S. FDA Record
Integra NeuroSciences Implants (France) S.A.S. has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Integra NeuroSciences Implants (France) S.A.S." is on file.
- Latest inspection
- Feb 12, 2015 · NAI
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 | 2 | Nov 14, 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 12, 2015 | Sophia Antipolis Cedex, France | Devices | No Action Indicated (NAI) | 3003813779 |
| Nov 20, 2008 | Sophia Antipolis Cedex, France | Devices | No Action Indicated (NAI) | 3003813779 |
- 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 3003813779 | Sophia Antipolis Cedex, France | 2 | Feb 12, 2015 |
Integra NeuroSciences Implants (France) S.A.S. and the FDA: common questions
Has Integra NeuroSciences Implants (France) S.A.S. received an FDA warning letter?
No FDA warning letter addressed to the name "Integra NeuroSciences Implants (France) S.A.S." 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 Integra NeuroSciences Implants (France) S.A.S. received an FDA Form 483?
FDA has not published a Form 483 for "Integra NeuroSciences Implants (France) S.A.S." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Integra NeuroSciences Implants (France) S.A.S.?
The most recent FDA inspection on file ended Feb 12, 2015 at Sophia Antipolis Cedex, France and was classified NAI. FDA has 2 inspections of Integra NeuroSciences Implants (France) S.A.S. on file.
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