FDA Inspection 679851 — Versiti Wisconsin, Inc
The FDA completed an inspection of Versiti Wisconsin, Inc on Aug 18, 2010 in Milwaukee, WI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 18, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Milwaukee, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 225 | 21 CFR 640.4(f) | Closed system |
| 57 | 21 CFR 606.60(a) | Maintain and clean equipment |
| 9225 | 21 CFR 606.171 | Biological product deviation report |