Uniao Quimica Farmaceutica Nacional SA FDA Record
- Latest inspection VAI · Aug 9, 2023
- No warning letters matched by name
Uniao Quimica Farmaceutica Nacional SA has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Uniao Quimica Farmaceutica Nacional SA" is on file.
- Latest inspection
- Aug 9, 2023 · VAI
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 | 5 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
Uniao Quimica Farmaceutica Nacional SA: FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 1 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 1 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Aug 9, 2023 | Guarulhos, Brazil | Veterinary | Voluntary Action Indicated (VAI) | 3004063802 |
| Aug 14, 2018 | Guarulhos, Brazil | Veterinary | Voluntary Action Indicated (VAI) | 3004063802 |
| Feb 23, 2016 | Guarulhos, Brazil | Veterinary | No Action Indicated (NAI) | 3004063802 |
| Dec 11, 2012 | Guarulhos, Brazil | Veterinary | Voluntary Action Indicated (VAI) | 3004063802 |
| Jun 10, 2010 | Guarulhos, Brazil | Veterinary | No Action Indicated (NAI) | 3004063802 |
- 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 3004063802 | Guarulhos, Brazil | 5 | Aug 9, 2023 |
Uniao Quimica Farmaceutica Nacional SA and the FDA: common questions
Has Uniao Quimica Farmaceutica Nacional SA received an FDA warning letter?
No FDA warning letter addressed to the name "Uniao Quimica Farmaceutica Nacional SA" 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 Uniao Quimica Farmaceutica Nacional SA received an FDA Form 483?
FDA has not published a Form 483 for "Uniao Quimica Farmaceutica Nacional SA" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Uniao Quimica Farmaceutica Nacional SA?
The most recent FDA inspection on file ended Aug 9, 2023 at Guarulhos, Brazil and was classified VAI. FDA has 5 inspections of Uniao Quimica Farmaceutica Nacional SA on file.
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