NEGOCIOS INDUSTRIALES REAL S-.A (NIRSA) FDA Record
NEGOCIOS INDUSTRIALES REAL S-.A (NIRSA) has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to NEGOCIOS INDUSTRIALES REAL S-.A (NIRSA), the most recent on Jan 23, 2012.
- Latest inspection
- Nov 11, 2016 · NAI
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 | 4 | 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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NEGOCIOS INDUSTRIALES REAL S-.A (NIRSA) FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Jan 23, 2012 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Nov 11, 2016 | Guayaquil, Ecuador | Food/Cosmetics | No Action Indicated (NAI) | 3009904675 |
| Apr 9, 2013 | Guayaquil, Ecuador | Food/Cosmetics | Voluntary Action Indicated (VAI) | 3009904675 |
| Aug 10, 2011 | Guayaquil, Ecuador | Food/Cosmetics | Official Action Indicated (OAI) | 3009904675 |
| Jan 20, 2009 | Guayaquil, Ecuador | Food/Cosmetics | Voluntary Action Indicated (VAI) | 3009904675 |
- 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 NEGOCIOS INDUSTRIALES REAL S-.A (NIRSA): warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3009904675 | Guayaquil, Ecuador | 4 | Nov 11, 2016 |
NEGOCIOS INDUSTRIALES REAL S-.A (NIRSA) and the FDA: common questions
Has NEGOCIOS INDUSTRIALES REAL S-.A (NIRSA) received an FDA warning letter?
Yes. FDA has issued 1 warning letter to NEGOCIOS INDUSTRIALES REAL S-.A (NIRSA). The most recent is dated Jan 23, 2012.
Has NEGOCIOS INDUSTRIALES REAL S-.A (NIRSA) received an FDA Form 483?
FDA has not published a Form 483 for "NEGOCIOS INDUSTRIALES REAL S-.A (NIRSA)" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect NEGOCIOS INDUSTRIALES REAL S-.A (NIRSA)?
The most recent FDA inspection on file ended Nov 11, 2016 at Guayaquil, Ecuador and was classified NAI. FDA has 4 inspections of NEGOCIOS INDUSTRIALES REAL S-.A (NIRSA) on file, 1 of them classified OAI (official action indicated).
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