CareHealth America FDA Record
- Latest inspection NAI · Jan 25, 2024
- Last warning letter 2014
CareHealth America has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 3 compliance actions on record. FDA has issued 3 warning letters to CareHealth America, the most recent on Sep 17, 2014.
- Latest inspection
- Jan 25, 2024 · 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 | 6 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 3 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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CareHealth America FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Sep 17, 2014 · Record page | |||
| Mar 24, 2011 · Record page | |||
| Mar 12, 2009 · Record page |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jan 25, 2024 | Blue Earth, MN | Devices | No Action Indicated (NAI) | 3014946040 |
| Sep 25, 2015 | Blue Earth, MN | Devices | No Action Indicated (NAI) | 3014946040 |
| Jun 24, 2014 | Blue Earth, MN | Devices | Official Action Indicated (OAI) | 3014946040 |
| Jul 13, 2011 | Blue Earth, MN | Devices | Voluntary Action Indicated (VAI) | 3014946040 |
| Jan 20, 2011 | Blue Earth, MN | Devices | Official Action Indicated (OAI) | 3014946040 |
| Oct 29, 2008 | Blue Earth, MN | Devices | Voluntary Action Indicated (VAI) | 3014946040 |
- 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.
Compliance Actions
FDA's compliance actions data lists 3 compliance actions under CareHealth America: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3014946040 | Blue Earth, MN | 6 | Jan 25, 2024 |
CareHealth America and the FDA: common questions
Has CareHealth America received an FDA warning letter?
Yes. FDA has issued 3 warning letters to CareHealth America. The most recent is dated Sep 17, 2014.
Has CareHealth America received an FDA Form 483?
FDA has not published a Form 483 for "CareHealth America" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect CareHealth America?
The most recent FDA inspection on file ended Jan 25, 2024 at Blue Earth, MN and was classified NAI. FDA has 6 inspections of CareHealth America on file, 2 of them classified OAI (official action indicated).
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