Citizen Systems Japan Co., Ltd. FDA Record
- Latest inspection NAI · Jun 22, 2016
- No warning letters matched by name
Citizen Systems Japan Co., Ltd. has 0 FDA recalls, 1 inspection, 4 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Citizen Systems Japan Co., Ltd." is on file.
- Latest inspection
- Jun 22, 2016 · NAI
- Latest 510(k)
- Sep 10, 2010
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 | 4 | 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 |
|---|---|---|---|---|
| Jun 22, 2016 | Tokyo, Japan | Devices | No Action Indicated (NAI) | 3005176386 |
- 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 3005176386 | Tokyo, Japan | 1 | Jun 22, 2016 |
Citizen Systems Japan Co., Ltd. and the FDA: common questions
Has Citizen Systems Japan Co., Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Citizen Systems Japan 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 Citizen Systems Japan Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Citizen Systems Japan Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Citizen Systems Japan Co., Ltd.?
The most recent FDA inspection on file ended Jun 22, 2016 at Tokyo, Japan and was classified NAI. FDA has 1 inspection of Citizen Systems Japan Co., Ltd. on file.
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