FDA Inspection 703010 — Wisconsin Diagnostic Laboratories, LLC
The FDA completed an inspection of Wisconsin Diagnostic Laboratories, LLC on December 22, 2010 in Milwaukee, WI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 22, 2010
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Milwaukee, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3443 | 21 CFR 610.47 | Notification of transfusion recipients |
| 9089 | 21 CFR 600.14(c) | When to report |
| 98 | 21 CFR 606.100(c) | Thorough investigations |