FDA Inspection 728741 — LifeServe Blood Center
The FDA completed an inspection of LifeServe Blood Center on June 7, 2011 in Sioux City, IA. 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) (VAI)
- End Date
- June 7, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Sioux City, IA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 4415 | 21 CFR 211.204 | Returned drug products with doubt cast as to safety et. al. |
| 91 | 21 CFR 606.100(b)(12) | Criteria for suitability of reissue of returned blood |