FDA Inspection 635815 — Versiti Wisconsin Inc. - Transfusion Service
The FDA completed an inspection of Versiti Wisconsin Inc. - Transfusion Service on Dec 17, 2009 in Wauwatosa, 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
- Dec 17, 2009
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Wauwatosa, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 61 | 21 CFR 606.60(a) | Provide proper equipment to meet requirements |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 98 | 21 CFR 606.100(c) | Thorough investigations |