FDA Inspection 1022840 — BioLife Plasma Services L.P.
The FDA completed an inspection of BioLife Plasma Services L.P. on August 25, 2017 in Greenwood, IN. 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) (VAI)
- End Date
- August 25, 2017
- Fiscal Year
- 2017
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Greenwood, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18093 | 21 CFR 630.10(g)(1) | Proof Of Identity |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |