United Health Products, Inc. FDA Record
- Latest inspection OAI · Oct 4, 2024
- Last warning letter 2025
United Health Products, Inc. has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. FDA has issued 1 warning letter to United Health Products, Inc., the most recent on Mar 24, 2025.
- Latest inspection
- Oct 4, 2024 · OAI
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 | 1 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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United Health Products, Inc. FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Mar 24, 2025 · Letter on fda.gov | Bioresearch Monitoring Program/Institutional Review Board (IRB) | Center for Devices and Radiological Health |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Oct 4, 2024 | Mount Laurel, NJ | Devices | Official Action Indicated (OAI) | 3011849720 |
- 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 3011849720 | Mount Laurel, NJ | 1 | Oct 4, 2024 |
United Health Products, Inc. and the FDA: common questions
Has United Health Products, Inc. received an FDA warning letter?
Yes. FDA has issued 1 warning letter to United Health Products, Inc.. The most recent is dated Mar 24, 2025, with the subject "Bioresearch Monitoring Program/Institutional Review Board (IRB)".
Has United Health Products, Inc. received an FDA Form 483?
FDA has not published a Form 483 for "United Health Products, Inc." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect United Health Products, Inc.?
The most recent FDA inspection on file ended Oct 4, 2024 at Mount Laurel, NJ and was classified OAI. FDA has 1 inspection of United Health Products, Inc. on file, 1 of them classified OAI (official action indicated).
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