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

Source: https://www.keypedia.com/records/483/united-health-products-inc/d96ef6e8-7c18-416d-a7d6-b6663e5b88c1

> FDA 483 for United Health Products, Inc. on October 04, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: United Health Products, Inc.
- Inspection Date: 2024-10-04
- Product Type: device
- Office Name: New Jersey District Office
- Summary: 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.

## Related Officers

- [investigator](https://www.keypedia.com/people/tyanna-n-hadley/8fdebfd7-d6f3-44ab-9dcb-864ab6d55d53)

Company: https://www.keypedia.com/companies/united-health-products-inc/70d25be8-5049-4141-8edc-2c2c1a447ab8

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248