FDA Inspection 884950 — LifeServe Blood Center
The FDA completed an inspection of LifeServe Blood Center on May 28, 2014 in Johnston, 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
- May 28, 2014
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Johnston, IA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12203 | 21 CFR 606.170(a) | Adverse Reaction- Reports of Investigations |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 41 | 21 CFR 606.40(a)(1) | Provide space for examination |