FDA Inspection 1143495 — BioLife Plasma Services L.P.
The FDA completed an inspection of BioLife Plasma Services L.P. on June 8, 2021 in Arlington, TX. 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 8, 2021
- Fiscal Year
- 2021
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Arlington, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 3620 | 21 CFR 640.76(a)(2) | Source plasma - storage temp fluctuation |
| 3642 | 21 CFR 640.76(c) | Source Plasma - Re-labeling |