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

Source: https://www.keypedia.com/records/483/heather-r-harrison-do/d55480ee-f912-4d51-bd4f-d48a9d3cac65

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

---

## 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 for postpartum depression. Observations included failures to follow the investigational plan, maintain accurate case histories, and adequately manage investigational drug disposition records. These issues indicate a lack of proper oversight and adherence to regulatory requirements for clinical studies.

## Related Documents

- [483 - 2018-09-19](https://www.keypedia.com/records/483/heather-r-harrison-do/e8a24c02-718b-4b82-9d84-c770a6409492)

## 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