St Louis Children's Hospital FDA Record
- Latest inspection VAI · Nov 20, 2025
- No warning letters matched by name
St Louis Children's Hospital has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "St Louis Children's Hospital" is on file.
- Latest inspection
- Nov 20, 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 | 7 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
St Louis Children's Hospital: 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 | 1 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Nov 20, 2025 | Saint Louis, MO | Biologics | Voluntary Action Indicated (VAI) | 1937473 |
| Nov 10, 2022 | Saint Louis, MO | Biologics | No Action Indicated (NAI) | 1937473 |
| Aug 28, 2018 | Saint Louis, MO | Biologics | No Action Indicated (NAI) | 1937473 |
| Jan 26, 2015 | Saint Louis, MO | Biologics | No Action Indicated (NAI) | 1937473 |
| Dec 10, 2012 | Saint Louis, MO | Biologics | No Action Indicated (NAI) | 1937473 |
| Jan 19, 2011 | Saint Louis, MO | Biologics | No Action Indicated (NAI) | 1937473 |
| Jun 11, 2009 | Saint Louis, MO | Biologics | No Action Indicated (NAI) | 1937473 |
- 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 1937473 | Saint Louis, MO | 7 | Nov 20, 2025 |
St Louis Children's Hospital and the FDA: common questions
Has St Louis Children's Hospital received an FDA warning letter?
No FDA warning letter addressed to the name "St Louis Children's Hospital" 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 Louis Children's Hospital received an FDA Form 483?
FDA has not published a Form 483 for "St Louis Children's Hospital" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect St Louis Children's Hospital?
The most recent FDA inspection on file ended Nov 20, 2025 at Saint Louis, MO and was classified VAI. FDA has 7 inspections of St Louis Children's Hospital on file.
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