Ogura Shokuhin Co Ltd FDA Record
Ogura Shokuhin Co Ltd has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Ogura Shokuhin Co Ltd, the most recent on May 1, 2024.
- Latest inspection
- Nov 17, 2009 · OAI
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 1 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Ogura Shokuhin Co Ltd FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| May 1, 2024 | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | Center for Food Safety and Applied Nutrition |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Nov 17, 2009 | Shizuoka, Japan | Food/Cosmetics | Official Action Indicated (OAI) | 1000203650 |
- 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.
Compliance Actions
FDA's compliance actions data lists 1 compliance action under Ogura Shokuhin Co Ltd: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 1000203650 | Shizuoka, Japan | 1 | Nov 17, 2009 |
Ogura Shokuhin Co Ltd and the FDA: common questions
Has Ogura Shokuhin Co Ltd received an FDA warning letter?
Yes. FDA has issued 1 warning letter to Ogura Shokuhin Co Ltd. The most recent is dated May 1, 2024, with the subject "Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions".
Has Ogura Shokuhin Co Ltd received an FDA Form 483?
FDA has not published a Form 483 for "Ogura Shokuhin Co Ltd" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Ogura Shokuhin Co Ltd?
The most recent FDA inspection on file ended Nov 17, 2009 at Shizuoka, Japan and was classified OAI. FDA has 1 inspection of Ogura Shokuhin Co Ltd on file, 1 of them classified OAI (official action indicated).
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