# FDA 483 - Michael W. Harris, D.O. - December 15, 2015

Source: https://www.keypedia.com/records/483/michael-w-harris-do/1ad10d6c-36aa-47e8-b7f8-93dc146ebe74

> FDA 483 for Michael W. Harris, D.O. on December 15, 2015. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Michael W. Harris, D.O.
- Inspection Date: 2015-12-15
- Product Type: drugs
- Office Name: Denver District Office
- Summary: An FDA inspection of Michael W. Harris, D.O., Clinical Investigator, in Orem, UT, revealed significant deviations from the investigational plan and inadequate record-keeping practices. The firm failed to properly assess and report serious adverse events, ensure subjects met screening criteria before enrollment, and report concomitant medications. Additionally, the investigator repeatedly backdated source documents, maintained inconsistent data, and mismanaged study records, highlighting severe data integrity issues.

## Related Documents

- [483 - 2019-05-24](https://www.keypedia.com/records/483/michael-w-harris-do/a29e019f-04b7-4f82-aa55-71ad2f89c0e3)

## Related Officers

- [investigator](https://www.keypedia.com/people/stephen-t-hansen/7ae1f1df-7f68-4264-bd87-ea21c8d879bb)

Company: https://www.keypedia.com/companies/michael-w-harris-do/f04a6e09-4c55-46a9-b9ce-6dda086d0480

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