Heartland Regional Med Center IRB FDA Record
- Latest inspection NAI · Jul 21, 2025
- No warning letters matched by name
Heartland Regional Med Center IRB has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Heartland Regional Med Center IRB" is on file.
- Latest inspection
- Jul 21, 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 | 2 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jul 21, 2025 | Saint Joseph, MO | Drugs | No Action Indicated (NAI) | 3002996053 |
| Nov 7, 2013 | Saint Joseph, MO | Devices | Voluntary Action Indicated (VAI) | 3002996053 |
- 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 3002996053 | Saint Joseph, MO | 2 | Jul 21, 2025 |
Heartland Regional Med Center IRB and the FDA: common questions
Has Heartland Regional Med Center IRB received an FDA warning letter?
No FDA warning letter addressed to the name "Heartland Regional Med Center IRB" 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 Heartland Regional Med Center IRB received an FDA Form 483?
FDA has not published a Form 483 for "Heartland Regional Med Center IRB" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Heartland Regional Med Center IRB?
The most recent FDA inspection on file ended Jul 21, 2025 at Saint Joseph, MO and was classified NAI. FDA has 2 inspections of Heartland Regional Med Center IRB on file.
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