FDA Inspection 707678 — LifeServe Blood Center
The FDA completed an inspection of LifeServe Blood Center on Jan 26, 2011 in Mitchell, SD. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 26, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Mitchell, SD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 227 | 21 CFR 640.4(h) | Storage temperatures after collection |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |