Showa Ika Kohgyo Co., Ltd. FDA Record
- Latest inspection VAI · Feb 7, 2013
- No warning letters matched by name
Showa Ika Kohgyo Co., Ltd. has 0 FDA recalls, 1 inspection, 2 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Showa Ika Kohgyo Co., Ltd." is on file.
- Latest inspection
- Feb 7, 2013 · VAI
- Latest 510(k)
- Jul 2, 2008
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 2 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 1 | Nov 14, 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 7, 2013 | Toyohashi, Japan | Devices | Voluntary Action Indicated (VAI) | 3004589749 |
- 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 3004589749 | Toyohashi, Japan | 1 | Feb 7, 2013 |
Showa Ika Kohgyo Co., Ltd. and the FDA: common questions
Has Showa Ika Kohgyo Co., Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Showa Ika Kohgyo 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 Showa Ika Kohgyo Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Showa Ika Kohgyo Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Showa Ika Kohgyo Co., Ltd.?
The most recent FDA inspection on file ended Feb 7, 2013 at Toyohashi, Japan and was classified VAI. FDA has 1 inspection of Showa Ika Kohgyo Co., Ltd. on file.
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