Seikagaku Corp. FDA Record
- Latest inspection NAI · Jul 19, 2019
- No warning letters matched by name
Seikagaku Corp. has 0 FDA recalls, 1 inspection, 1 510(k) clearance and 0 compliance actions on record. No FDA warning letter addressed to "Seikagaku Corp." is on file.
- Latest inspection
- Jul 19, 2019 · NAI
- Latest 510(k)
- Aug 15, 2001
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 | 1 | 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 |
|---|---|---|---|---|
| Jul 19, 2019 | Takahagi, Japan | Devices | No Action Indicated (NAI) | 1000255210 |
- 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 1000255210 | Takahagi, Japan | 1 | Jul 19, 2019 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K011544 | HADGEL, 4 GRAM/SYRINGE | Aug 15, 2001 |
Seikagaku Corp. and the FDA: common questions
Has Seikagaku Corp. received an FDA warning letter?
No FDA warning letter addressed to the name "Seikagaku Corp." 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 Seikagaku Corp. received an FDA Form 483?
FDA has not published a Form 483 for "Seikagaku Corp." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Seikagaku Corp.?
The most recent FDA inspection on file ended Jul 19, 2019 at Takahagi, Japan and was classified NAI. FDA has 1 inspection of Seikagaku Corp. on file.
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