FDA Inspection 741493 — LifeServe Blood Center
The FDA completed an inspection of LifeServe Blood Center on August 25, 2011 in Johnston, IA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- August 25, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Johnston, IA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2032 | 21 CFR 211.194(b) | Test method modification records not maintained |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |