# Breelyn A Wilky MD – FDA 483, Jun 25, 2026

Source: https://www.keypedia.com/records/483/breelyn-a-wilky-md/a08bd703-b211-4304-a2ab-ddcbbab2c838

> FDA 483 for Breelyn A Wilky MD on June 25, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Breelyn A Wilky MD
- Inspection Date: 2026-06-25
- Product Type: drugs
- Office Name: Denver District Office
- Summary: An FDA inspection of Breelyn A Wilky MD in Aurora, CO, a clinical investigator, revealed significant deficiencies in clinical trial conduct. Observations included failure to obtain legally effective informed consent, conducting an investigation not in accordance with the signed statement of investigator, and inadequate maintenance of accurate case histories. These issues indicate serious concerns regarding subject protection, protocol adherence, and data integrity in clinical studies.

## Related Officers

- [Theressa B. Smith](https://www.keypedia.com/people/theressa-b-smith/80f0c339-7eac-4c73-b9f6-ecb368738fe6)

Company: https://www.keypedia.com/companies/breelyn-a-wilky-md/3327e67f-cdb5-41ca-bdfe-7b4b284a81ad

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