Texas Children's Hospital - West Campus FDA Record
- Latest inspection NAI · Mar 27, 2025
- No warning letters matched by name
Texas Children's Hospital - West Campus has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Texas Children's Hospital - West Campus" is on file.
- Latest inspection
- Mar 27, 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 | 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
Texas Children's Hospital - West Campus: FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 1 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 1 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 1 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Mar 27, 2025 | Houston, TX | Biologics | No Action Indicated (NAI) | 3009583088 |
| Aug 23, 2022 | Houston, TX | Biologics | No Action Indicated (NAI) | 3009583088 |
| Sep 25, 2017 | Houston, TX | Biologics | No Action Indicated (NAI) | 3009583088 |
| Sep 30, 2015 | Houston, TX | Biologics | Voluntary Action Indicated (VAI) | 3009583088 |
| Mar 19, 2013 | Houston, TX | Biologics | No Action Indicated (NAI) | 3009583088 |
- 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 3009583088 | Houston, TX | 5 | Mar 27, 2025 |
Texas Children's Hospital - West Campus and the FDA: common questions
Has Texas Children's Hospital - West Campus received an FDA warning letter?
No FDA warning letter addressed to the name "Texas Children's Hospital - West Campus" 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 - West Campus received an FDA Form 483?
FDA has not published a Form 483 for "Texas Children's Hospital - West Campus" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Texas Children's Hospital - West Campus?
The most recent FDA inspection on file ended Mar 27, 2025 at Houston, TX and was classified NAI. FDA has 5 inspections of Texas Children's Hospital - West Campus on file.
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