1064057
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 30, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Englewood, CO (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 3003 | 21 CFR 812.140(b)(6) | Other sponsor records required by FDA inadequate |