FDA Inspection 654608 — Sanford Medical Center
The FDA completed an inspection of Sanford Medical Center on Mar 26, 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). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 26, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Sioux Falls, SD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 160 | 21 CFR 606.160(a)(1) | Person performing, test results, interpretation |
| 224 | 21 CFR 640.4(f) | Arm preparation |
| 247 | 21 CFR 640.24(b) | Storage until removal of platelets |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |