# FDA 483 - Val R. Hansen, M.D. - September 03, 2021

Source: https://www.keypedia.com/records/483/val-r-hansen-md/6e0d650d-08fd-45e0-bdae-473b9132d49a

> FDA 483 for Val R. Hansen, M.D. on September 03, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Val R. Hansen, M.D.
- Inspection Date: 2021-09-03
- Product Type: drugs
- Office Name: Denver District Office
- Summary: Val R. Hansen, MD, a Clinical Investigator in Bountiful, UT, was cited for significant deviations from an investigational plan and inadequate record-keeping. Observations included failing to conduct subject visits within required windows and insufficient oversight of study staff regarding serious adverse event reporting. Additionally, the firm failed to maintain accurate case histories, evidenced by incorrect lab review dates and missing source documents.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/courtney-r-bratina/3ad4bfd5-d0da-4801-8e90-a5a3ba9291c3)

Company: https://www.keypedia.com/companies/val-r-hansen-md/821e071c-d0b8-4619-99e4-c3b078fbf17d

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face