Warning letter
United Health Products, Inc.: warning letter of Mar 24, 2025
FDA warning letter 697777 · Center for Devices and Radiological Health
Key facts
| Reference number | 697777 |
|---|---|
| Company | United Health Products, Inc. |
| Subject | Bioresearch Monitoring Program/Institutional Review Board (IRB) |
| Issue date | Mar 24, 2025 |
| Posted date | May 20, 2025 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 812.46(b)(1), 812.100, 812.140(b)(2), 812.20(a), 812.20(a)(1), 812.150(b)(1), 878.4490, 50, 812, 812.3(m), 812.40, 812.46(a) |
| Inspection city | Mount Laurel |
| Inspection ZIP | 08054 |
| Inspection start date | Sep 23, 2024 |
| Letter on fda.gov | fda.gov |
At a glance
- 10–99 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: