Kitazato Medical Co., Ltd. FDA Record
- Latest inspection NAI · Sep 3, 2015
- No warning letters matched by name
Kitazato Medical Co., Ltd. has 0 FDA recalls, 1 inspection, 3 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Kitazato Medical Co., Ltd." is on file.
- Latest inspection
- Sep 3, 2015 · NAI
- Latest 510(k)
- Sep 11, 2013
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 | 3 | 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 |
|---|---|---|---|---|
| Sep 3, 2015 | Minato, Japan | Devices | No Action Indicated (NAI) | 3008456389 |
- 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 3008456389 | Minato, Japan | 1 | Sep 3, 2015 |
Kitazato Medical Co., Ltd. and the FDA: common questions
Has Kitazato Medical Co., Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Kitazato Medical Co., Ltd." 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 Kitazato Medical Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Kitazato Medical Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Kitazato Medical Co., Ltd.?
The most recent FDA inspection on file ended Sep 3, 2015 at Minato, Japan and was classified NAI. FDA has 1 inspection of Kitazato Medical Co., Ltd. on file.
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