Children's Mercy Hospital And Clinics FDA Record
- Latest inspection NAI · Jul 16, 2025
- No warning letters matched by name
Children's Mercy Hospital And Clinics has 0 FDA recalls, 8 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Children's Mercy Hospital And Clinics" is on file.
- Latest inspection
- Jul 16, 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
Children's Mercy Hospital And Clinics: 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 | 1 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 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 |
|---|---|---|---|---|
| Jul 16, 2025 | Kansas City, MO | Biologics | No Action Indicated (NAI) | 1974136 |
| Feb 10, 2023 | Kansas City, MO | Biologics | No Action Indicated (NAI) | 1974136 |
| Aug 20, 2018 | Kansas City, MO | Biologics | No Action Indicated (NAI) | 1974136 |
| Mar 28, 2016 | Kansas City, MO | Biologics | No Action Indicated (NAI) | 1974136 |
| Jun 25, 2014 | Kansas City, MO | Biologics | No Action Indicated (NAI) | 1974136 |
| Jun 7, 2012 | Kansas City, MO | Biologics | No Action Indicated (NAI) | 1974136 |
| Oct 28, 2010 | Kansas City, MO | Biologics | No Action Indicated (NAI) | 1974136 |
| Apr 7, 2009 | Kansas City, MO | Biologics | No Action Indicated (NAI) | 1974136 |
- 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 1974136 | Kansas City, MO | 8 | Jul 16, 2025 |
Children's Mercy Hospital And Clinics and the FDA: common questions
Has Children's Mercy Hospital And Clinics received an FDA warning letter?
No FDA warning letter addressed to the name "Children's Mercy Hospital And Clinics" 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 Children's Mercy Hospital And Clinics received an FDA Form 483?
FDA has not published a Form 483 for "Children's Mercy Hospital And Clinics" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Children's Mercy Hospital And Clinics?
The most recent FDA inspection on file ended Jul 16, 2025 at Kansas City, MO and was classified NAI. FDA has 8 inspections of Children's Mercy Hospital And Clinics on file.
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