Greiner Bio One Brasil Produtos Medicos Hospitalares Ltda. FDA Record
- Latest inspection NAI · Jan 16, 2014
- Last warning letter 2014
Greiner Bio One Brasil Produtos Medicos Hospitalares Ltda. has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Greiner Bio One Brasil Produtos Medicos Hospitalares Ltda., the most recent on Aug 8, 2014.
- Latest inspection
- Jan 16, 2014 · NAI
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 | 0 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 1 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Greiner Bio One Brasil Produtos Medicos Hospitalares Ltda. FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Aug 8, 2014 · Record page |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jan 16, 2014 | Americana, Brazil | Devices | No Action Indicated (NAI) | 3005674478 |
- 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 Greiner Bio One Brasil Produtos Medicos Hospitalares Ltda.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3005674478 | Americana, Brazil | 1 | Jan 16, 2014 |
Greiner Bio One Brasil Produtos Medicos Hospitalares Ltda. and the FDA: common questions
Has Greiner Bio One Brasil Produtos Medicos Hospitalares Ltda. received an FDA warning letter?
Yes. FDA has issued 1 warning letter to Greiner Bio One Brasil Produtos Medicos Hospitalares Ltda.. The most recent is dated Aug 8, 2014.
Has Greiner Bio One Brasil Produtos Medicos Hospitalares Ltda. received an FDA Form 483?
FDA has not published a Form 483 for "Greiner Bio One Brasil Produtos Medicos Hospitalares Ltda." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Greiner Bio One Brasil Produtos Medicos Hospitalares Ltda.?
The most recent FDA inspection on file ended Jan 16, 2014 at Americana, Brazil and was classified NAI. FDA has 1 inspection of Greiner Bio One Brasil Produtos Medicos Hospitalares Ltda. on file.
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