The Children's Hospital Corporation
FDA Regulatory Profile
The Children's Hospital Corporation has 0 FDA recalls, 6 inspections, 1 510(k) clearance and 0 compliance actions on record.
- Latest inspection
- Jul 11, 2025 · NAI
- Latest 510(k)
- Oct 29, 2001
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 0 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 1 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 6 | Nov 10, 2026 | Newest record Nov 5, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Jul 11, 2025 | Washington, DC | Biologics | No Action Indicated (NAI) | 3004467224 |
| Jul 10, 2024 | Boston, MA | Biologics | No Action Indicated (NAI) | 1274061 |
| Aug 2, 2019 | Boston, MA | Biologics | No Action Indicated (NAI) | 1274061 |
| Feb 14, 2017 | Boston, MA | Biologics | Voluntary Action Indicated (VAI) | 1274061 |
| Sep 26, 2014 | Boston, MA | Biologics | Voluntary Action Indicated (VAI) | 1274061 |
| Jul 28, 2010 | Boston, MA | Biologics | No Action Indicated (NAI) | 1274061 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K013458 | CRANIAL HELMET | Oct 29, 2001 |