1103189
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 25, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Round Lake, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3465 | 21 CFR 640.81(c) | Microbial contamination |
| 6011 | 21 CFR 123.8(a)(3)(ii) | Corrective action record review adequacy |
| 6801 | 21 CFR 807.22(a) | Initial registration and listing |