FDA 483 - United Health Products, Inc. - October 04, 2024

United Health Products, Inc. in Mount Laurel, NJ, was inspected regarding its corporate headquarters and found to have significant deficiencies in the conduct and oversight of investigational device studies. The inspection revealed inadequate monitoring, poor record-keeping, and failures in adverse event reporting. Additionally, the firm promoted an investigational device without FDA approval and failed to include required labeling information.