Texas Children's Hospital North Austin FDA Record
- Latest inspection VAI · Sep 17, 2025
- No warning letters matched by name
Texas Children's Hospital North Austin has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Texas Children's Hospital North Austin" is on file.
- Latest inspection
- Sep 17, 2025 · VAI
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 |
|---|---|---|---|---|
| Sep 17, 2025 | Austin, TX | Biologics | Voluntary Action Indicated (VAI) | 3026821507 |
- 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 3026821507 | Austin, TX | 1 | Sep 17, 2025 |
Texas Children's Hospital North Austin and the FDA: common questions
Has Texas Children's Hospital North Austin received an FDA warning letter?
No FDA warning letter addressed to the name "Texas Children's Hospital North Austin" 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 Texas Children's Hospital North Austin received an FDA Form 483?
FDA has not published a Form 483 for "Texas Children's Hospital North Austin" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Texas Children's Hospital North Austin?
The most recent FDA inspection on file ended Sep 17, 2025 at Austin, TX and was classified VAI. FDA has 1 inspection of Texas Children's Hospital North Austin on file.
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