FDA Inspection 638368 — Versiti Illinois Inc
The FDA completed an inspection of Versiti Illinois Inc on Jan 14, 2010 in Aurora, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 14, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Aurora, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 9005 | 21 CFR 606.100(b)(19) | Notification of consignees re: antibody test results |
| 98 | 21 CFR 606.100(c) | Thorough investigations |