Sagami Rubber Industries Co., Ltd. FDA Record
Sagami Rubber Industries Co., Ltd. has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Sagami Rubber Industries Co., Ltd., the most recent on Nov 24, 2015.
- Latest inspection
- Jul 24, 2015 · VAI
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 | 2 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Sagami Rubber Industries Co., Ltd. FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Nov 24, 2015 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jul 24, 2015 | Atsugi, Japan | Devices | Voluntary Action Indicated (VAI) | 3002808077 |
| Feb 4, 2011 | Atsugi, Japan | Devices | Voluntary Action Indicated (VAI) | 3002808077 |
- 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 Sagami Rubber Industries Co., Ltd.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3002808077 | Atsugi, Japan | 2 | Jul 24, 2015 |
Sagami Rubber Industries Co., Ltd. and the FDA: common questions
Has Sagami Rubber Industries Co., Ltd. received an FDA warning letter?
Yes. FDA has issued 1 warning letter to Sagami Rubber Industries Co., Ltd.. The most recent is dated Nov 24, 2015.
Has Sagami Rubber Industries Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Sagami Rubber Industries Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Sagami Rubber Industries Co., Ltd.?
The most recent FDA inspection on file ended Jul 24, 2015 at Atsugi, Japan and was classified VAI. FDA has 2 inspections of Sagami Rubber Industries Co., Ltd. on file.
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