FDA Inspection 976252 — Versiti Wisconsin, Inc
The FDA completed an inspection of Versiti Wisconsin, Inc on Jun 16, 2016 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). 2 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 16, 2016
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Milwaukee, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18082 | 21 CFR 630.10(e)(2) | Additional Medical Assessment Factors |
| 9262 | 21 CFR 610.40(b) | One or more approved screening tests |