FDA Inspection 726085 — Huron Regional Medical Center Blood Bank
The FDA completed an inspection of Huron Regional Medical Center Blood Bank on April 27, 2011 in Huron, SD. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 27, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Huron, SD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 42 | 21 CFR 606.40(a)(2) | Provide space for blood withdrawal |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |