FDA Inspection 673560 — Avera McKennan Hospital & University Health Center
The FDA completed an inspection of Avera McKennan Hospital & University Health Center on Jul 1, 2010 in Sioux Falls, SD. 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)
- End Date
- Jul 1, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Sioux Falls, SD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 67 | 21 CFR 606.65(e) | Following manufacturer's instructions |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9234 | 21 CFR 630.40(c) | Notification w/in 8 weeks |