KANEKA MEDIX CORPORATION KANAGAWA PLANT FDA Record
- Latest inspection NAI · Jan 30, 2025
- No warning letters matched by name
KANEKA MEDIX CORPORATION KANAGAWA PLANT has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "KANEKA MEDIX CORPORATION KANAGAWA PLANT" is on file.
- Latest inspection
- Jan 30, 2025 · NAI
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 | 0 | 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 |
|---|---|---|---|---|
| Jan 30, 2025 | Ashigarakami-Gun, Japan | Devices | No Action Indicated (NAI) | 3009761573 |
- 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 3009761573 | Ashigarakami-Gun, Japan | 1 | Jan 30, 2025 |
KANEKA MEDIX CORPORATION KANAGAWA PLANT and the FDA: common questions
Has KANEKA MEDIX CORPORATION KANAGAWA PLANT received an FDA warning letter?
No FDA warning letter addressed to the name "KANEKA MEDIX CORPORATION KANAGAWA PLANT" 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 KANEKA MEDIX CORPORATION KANAGAWA PLANT received an FDA Form 483?
FDA has not published a Form 483 for "KANEKA MEDIX CORPORATION KANAGAWA PLANT" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect KANEKA MEDIX CORPORATION KANAGAWA PLANT?
The most recent FDA inspection on file ended Jan 30, 2025 at Ashigarakami-Gun, Japan and was classified NAI. FDA has 1 inspection of KANEKA MEDIX CORPORATION KANAGAWA PLANT on file.
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