FDA Inspection 1287220 — Edmundowicz, Dr Steven
The FDA completed an inspection of Edmundowicz, Dr Steven on Oct 9, 2025 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). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 9, 2025
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Aurora, CO (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 14505 | 21 CFR 812.140(a)(3) | Investigator's subject records inadequate |
| 2968 | 21 CFR 812.100 | Investigator non-compliance with agreement/plan/regulations |
| 2980 | 21 CFR 812.140(a)(1) | Investigator correspondence records inadequate |
| 2985 | 21 CFR 812.140(a)(3)(ii) | Investigator records of relevant observations inadequate |
| 3025 | 21 CFR 812.150(a)(3) | No investigator progress reports |