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# ‘Serious’ Research Issues at United Health Products: FDA
- URL: https://www.fdaweb.com/serious-research-issues-at-united-health-products-fda/
- Published: 2025-05-22T12:00:00.000Z
- Updated: 2026-09-14T15:12:30.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5159234

A 9/23-10/4/2024 FDA Bioresearch Monitoring Program inspection at United Health Products in Mt. Laurel, NJ, identified serious violations in the firm’s conduct of research involving the CelluSTAT absorbable hemostat. A just-released 3/24 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/united-health-products-inc-697777-03242025?ref=fdaweb.com) says the specific violations were:

- failure to submit an IDE application to FDA and failure to obtain FDA approval before beginning an investigation for which FDA approval is required;
- failure to ensure proper monitoring of the investigation;
- failure to secure the clinical investigator’s compliance with the signed agreement, the investigational plan, applicable FDA regulations, and any other conditions of approval imposed by the reviewing institutional review board or FDA or, if compliance could not be obtained, failure to discontinue shipments of the device to the investigator and terminate the investigator’s participation in the investigation;
- failure to immediately evaluate any unanticipated adverse device effects and failure to report results of such an evaluation to FDA and to all reviewing institutional review boards and participating investigators within 10 working days; and
- failure to maintain accurate, complete, and current device shipment and disposition records.

The letter says United’s responses to the inspection observations shown on a form FDA-483 were inadequate. The company was told to provide documentation of the additional corrective and preventive actions it has taken or will take to correct the violations and prevent their recurrence.