FDA Inspection 773846 — LifeStream Blood Bank
The FDA completed an inspection of LifeStream Blood Bank on Mar 9, 2012 in La Quinta, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 9, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- La Quinta, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 218 | 21 CFR 640.3(c)(2) | History of viral hepatitis - close contact |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |