# FDA 483 - HEATHER R. HARRISON, D.O. - September 19, 2018

Source: https://www.keypedia.com/records/483/heather-r-harrison-do/e8a24c02-718b-4b82-9d84-c770a6409492

> FDA 483 for HEATHER R. HARRISON, D.O. on September 19, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: HEATHER R. HARRISON, D.O.
- Inspection Date: 2018-09-19
- Product Type: drugs
- Office Name: Denver District Office
- Summary: An FDA inspection of HEATHER R. HARRISON, D.O. in Orem, UT, a clinical investigator, revealed significant deficiencies in the conduct of a clinical trial. The firm failed to provide adequate oversight of its site management organization, resulting in issues with subject enrollment, protocol adherence, and personnel qualifications. Additionally, the inspection found widespread failures in maintaining accurate and complete case histories, informed consent documentation, and investigational drug disposition records.

## Related Documents

- [483 - 2018-09-19](https://www.keypedia.com/records/483/heather-r-harrison-do/d55480ee-f912-4d51-bd4f-d48a9d3cac65)

## Related Officers

- [investigator](https://www.keypedia.com/people/stephen-t-hansen/7ae1f1df-7f68-4264-bd87-ea21c8d879bb)
- [Theressa B. Smith](https://www.keypedia.com/people/theressa-b-smith/80f0c339-7eac-4c73-b9f6-ecb368738fe6)
- [Dawn C. Olenjack](https://www.keypedia.com/people/dawn-c-olenjack/b5a18d10-cd4b-405e-9016-8f5274a33000)

Company: https://www.keypedia.com/companies/heather-r-harrison-do/d60af014-efa4-4166-9405-ea6aa6cfe5fd

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