951842
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 21, 2015
- Fiscal Year
- 2015
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Aurora, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12243 | 21 CFR 1271.55(d)(1) | Documentation maintained (general) |
| 12473 | 21 CFR 1271.350(b)(2) | Deviations not reported to FDA |