Nihon Kohden Corporation - Tokorozawa Technical Center FDA Record
- Latest inspection VAI · Jan 24, 2024
- No warning letters matched by name
Nihon Kohden Corporation - Tokorozawa Technical Center has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Nihon Kohden Corporation - Tokorozawa Technical Center" is on file.
- Latest inspection
- Jan 24, 2024 · VAI
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 | 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 |
|---|---|---|---|---|
| Jan 24, 2024 | Tokorozawa, Japan | Devices | Voluntary Action Indicated (VAI) | 3013501110 |
- 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 3013501110 | Tokorozawa, Japan | 1 | Jan 24, 2024 |
Nihon Kohden Corporation - Tokorozawa Technical Center and the FDA: common questions
Has Nihon Kohden Corporation - Tokorozawa Technical Center received an FDA warning letter?
No FDA warning letter addressed to the name "Nihon Kohden Corporation - Tokorozawa Technical Center" 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 Nihon Kohden Corporation - Tokorozawa Technical Center received an FDA Form 483?
FDA has not published a Form 483 for "Nihon Kohden Corporation - Tokorozawa Technical Center" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Nihon Kohden Corporation - Tokorozawa Technical Center?
The most recent FDA inspection on file ended Jan 24, 2024 at Tokorozawa, Japan and was classified VAI. FDA has 1 inspection of Nihon Kohden Corporation - Tokorozawa Technical Center on file.
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