FDA Inspection 666770 — BioLife Plasma Services L.P.
The FDA completed an inspection of BioLife Plasma Services L.P. on June 2, 2010 in Sioux City, 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
- June 2, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Sioux City, IA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3258 | 21 CFR 640.63(d) | Unreliable answers |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9238 | 21 CFR 630.40(b)(3) | Results of testing |