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

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.