FDA Inspection 682680 — LifeStream Blood Bank
The FDA completed an inspection of LifeStream Blood Bank on Sep 24, 2010 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). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 24, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- La Quinta, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12203 | 21 CFR 606.170(a) | Adverse Reaction- Reports of Investigations |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |