FDA Inspection 1323706 — Breelyn A Wilky MD
The FDA completed an inspection of Breelyn A Wilky MD on Jun 25, 2026 in Aurora, CO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 25, 2026
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Aurora, CO (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 7231 | 21 CFR 50.20 | Consent not obtained, exceptions do not apply |
| 7530 | 21 CFR 312.62(b) | Case history records- inadequate or inadequate |
| 7560 | 21 CFR 312.60 | FD-1572, protocol compliance |