# FDA 483 - Michael W. Harris, D.O. - May 24, 2019

Source: https://www.keypedia.com/records/483/michael-w-harris-do/a29e019f-04b7-4f82-aa55-71ad2f89c0e3

> FDA 483 for Michael W. Harris, D.O. on May 24, 2019. 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: 2019-05-24
- Product Type: drugs
- Office Name: Denver District Office
- Summary: Aspen Clinical Research was cited for significant deficiencies in conducting clinical investigations, including repeated failures to ensure subjects met screening criteria, inadequate evaluation of drug screens, and non-compliance with dosing protocols. The firm also used unqualified staff for study assessments, failed to follow protocol for various activities, and submitted inaccurate information to the IRB. Additionally, issues were noted with investigational drug disposition records and the maintenance of accurate case histories.

## Related Documents

- [483 - 2015-12-15](https://www.keypedia.com/records/483/michael-w-harris-do/1ad10d6c-36aa-47e8-b7f8-93dc146ebe74)

## Related Officers

- [Theressa B. Smith](https://www.keypedia.com/people/theressa-b-smith/80f0c339-7eac-4c73-b9f6-ecb368738fe6)
- [issuing_officer](https://www.keypedia.com/people/ruth-a-williams/f6dd5e30-fe9a-4b18-9703-dc471a55f24f)

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