FDA Inspection 809597 — Avera Sacred Heart Hospital/Blood Bank
The FDA completed an inspection of Avera Sacred Heart Hospital/Blood Bank on November 28, 2012 in Yankton, SD. 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
- November 28, 2012
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Yankton, SD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |