FDA Inspection 1018476 — Saint Elizabeth Hospital Laboratory
The FDA completed an inspection of Saint Elizabeth Hospital Laboratory on March 8, 2017 in Appleton, WI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 8, 2017
- Fiscal Year
- 2017
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Appleton, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18038 | 21 CFR 606.100(b) | SOPs for investigations, records |