St. Jude Medical Brasil Ltda FDA Record
- Latest inspection NAI · Apr 18, 2013
- No warning letters matched by name
St. Jude Medical Brasil Ltda has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "St. Jude Medical Brasil Ltda" is on file.
- Latest inspection
- Apr 18, 2013 · 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 | 2 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Apr 18, 2013 | Belo Horizonte, Brazil | Devices | No Action Indicated (NAI) | 3001883144 |
| Feb 17, 2011 | Nova Lima, Brazil | Devices | No Action Indicated (NAI) | 3001743903 |
- 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 3001883144 | Belo Horizonte, Brazil | 1 | Apr 18, 2013 |
| FEI 3001743903 | Nova Lima, Brazil | 1 | Feb 17, 2011 |
St. Jude Medical Brasil Ltda and the FDA: common questions
Has St. Jude Medical Brasil Ltda received an FDA warning letter?
No FDA warning letter addressed to the name "St. Jude Medical Brasil Ltda" 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 St. Jude Medical Brasil Ltda received an FDA Form 483?
FDA has not published a Form 483 for "St. Jude Medical Brasil Ltda" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect St. Jude Medical Brasil Ltda?
The most recent FDA inspection on file ended Apr 18, 2013 at Belo Horizonte, Brazil and was classified NAI. FDA has 2 inspections of St. Jude Medical Brasil Ltda on file.
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