Kyocera Corporation FDA Record
- Latest inspection VAI · Feb 28, 2014
- No warning letters matched by name
Kyocera Corporation has 0 FDA recalls, 2 inspections, 1 510(k) clearance and 0 compliance actions on record. No FDA warning letter addressed to "Kyocera Corporation" is on file.
- Latest inspection
- Feb 28, 2014 · VAI
- Latest 510(k)
- Dec 5, 2024
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 | 1 | 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 28, 2014 | Kyoto, Japan | Devices | Voluntary Action Indicated (VAI) | 3010566635 |
| Oct 7, 2010 | Kyoto, Japan | Devices | Voluntary Action Indicated (VAI) | 3010566635 |
- 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 3010566635 | Kyoto, Japan | 2 | Feb 28, 2014 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K243444 | BIOCERAM AZUL® HEAD | Dec 5, 2024 |
Kyocera Corporation and the FDA: common questions
Has Kyocera Corporation received an FDA warning letter?
No FDA warning letter addressed to the name "Kyocera Corporation" 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 Kyocera Corporation received an FDA Form 483?
FDA has not published a Form 483 for "Kyocera Corporation" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Kyocera Corporation?
The most recent FDA inspection on file ended Feb 28, 2014 at Kyoto, Japan and was classified VAI. FDA has 2 inspections of Kyocera Corporation on file.
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