Johns Hopkins All Children's Hospital FDA Record
- Latest inspection NAI · Jun 12, 2025
- No warning letters matched by name
Johns Hopkins All Children's Hospital has 0 FDA recalls, 8 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Johns Hopkins All Children's Hospital" is on file.
- Latest inspection
- Jun 12, 2025 · NAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 0 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 8 | 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
Johns Hopkins All 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 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 1 | 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 |
|---|---|---|---|---|
| Jun 12, 2025 | St Petersburg, FL | Biologics | No Action Indicated (NAI) | 1000222202 |
| Feb 13, 2020 | St Petersburg, FL | Biologics | No Action Indicated (NAI) | 1000222202 |
| Aug 16, 2017 | St Petersburg, FL | Biologics | No Action Indicated (NAI) | 1000222202 |
| Aug 20, 2015 | St Petersburg, FL | Biologics | No Action Indicated (NAI) | 1000222202 |
| Nov 7, 2013 | St Petersburg, FL | Biologics | No Action Indicated (NAI) | 1000222202 |
| Jan 19, 2012 | St Petersburg, FL | Biologics | No Action Indicated (NAI) | 1000222202 |
| Apr 29, 2010 | St Petersburg, FL | Biologics | Voluntary Action Indicated (VAI) | 1000222202 |
| Feb 12, 2009 | St Petersburg, FL | Biologics | No Action Indicated (NAI) | 1000222202 |
- 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 1000222202 | St Petersburg, FL | 8 | Jun 12, 2025 |
Johns Hopkins All Children's Hospital and the FDA: common questions
Has Johns Hopkins All Children's Hospital received an FDA warning letter?
No FDA warning letter addressed to the name "Johns Hopkins All 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 Johns Hopkins All Children's Hospital received an FDA Form 483?
FDA has not published a Form 483 for "Johns Hopkins All Children's Hospital" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Johns Hopkins All Children's Hospital?
The most recent FDA inspection on file ended Jun 12, 2025 at St Petersburg, FL and was classified NAI. FDA has 8 inspections of Johns Hopkins All Children's Hospital on file.
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