Bluebonnett Ethical Review IRB FDA Record
- Latest inspection NAI · Aug 28, 2025
- No warning letters matched by name
Bluebonnett Ethical Review IRB has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Bluebonnett Ethical Review IRB" is on file.
- Latest inspection
- Aug 28, 2025 · 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 | 1 | 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 |
|---|---|---|---|---|
| Aug 28, 2025 | Lockhart, TX | Devices | No Action Indicated (NAI) | 3030225233 |
- 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 3030225233 | Lockhart, TX | 1 | Aug 28, 2025 |
Bluebonnett Ethical Review IRB and the FDA: common questions
Has Bluebonnett Ethical Review IRB received an FDA warning letter?
No FDA warning letter addressed to the name "Bluebonnett Ethical Review IRB" 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 Bluebonnett Ethical Review IRB received an FDA Form 483?
FDA has not published a Form 483 for "Bluebonnett Ethical Review IRB" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Bluebonnett Ethical Review IRB?
The most recent FDA inspection on file ended Aug 28, 2025 at Lockhart, TX and was classified NAI. FDA has 1 inspection of Bluebonnett Ethical Review IRB on file.
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