FDA Inspection 754383 — BioLife Plasma Services L.P.
The FDA completed an inspection of BioLife Plasma Services L.P. on November 22, 2011 in Elkhart, IN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 22, 2011
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Elkhart, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 77 | 21 CFR 606.100(b) | Written SOPs available for use by personnel |