FDA WARNING_LETTER - United Health Products, Inc. - October 04, 2024

On March 24, 2025, the FDA issued a Warning Letter to United Health Products, Inc. following an inspection from September 23 to October 4, 2024. The inspection, part of the Bioresearch Monitoring (BIMO) Program, assessed compliance for the "Efficacy and Safety of HemoStyp as an Adjunct for Management of Secondary Hemostasis in the Operative Setting" clinical study for CelluSTAT Absorbable Hemostat, a Class III device.

The FDA identified serious violations of 21 CFR Part 812 (Investigational Device Exemptions) and 21 CFR Part 50 (Protection of Human Subjects). Key violations include:

1. **Failure to Submit and Obtain IDE Approval:** United Health Products, Inc. conducted study UHP001, a significant risk device investigation, without submitting an IDE application or obtaining FDA approval. The company misrepresented FDA's risk determination to the IRB by modifying official FDA correspondence. 2. **Failure to Ensure Proper Monitoring:** The company lacked an effective and implemented Clinical Monitoring Plan (CMP) and failed to maintain adequate documentation for site initiation visits (SIVs) and interim monitoring visits. 3. **Failure to Secure Clinical Investigator Compliance:** The sponsor failed to ensure investigators adhered to the investigational plan, leading to enrollment of subjects who met exclusion criteria (e.g., thrombocytopenia) and failure to obtain