1292868
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 24, 2025
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Louisville, CO (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 2928 | 21 CFR 812.40 | Sponsors' general responsibilities |
| 2949 | 21 CFR 812.46(a) | Sponsor securing investigator compliance |
| 3003 | 21 CFR 812.140(b)(6) | Other sponsor records required by FDA inadequate |