FDA Inspection 1294356 — BioLife Plasma Services LP
The FDA completed an inspection of BioLife Plasma Services LP on December 5, 2025 in Fort Worth, 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
- December 5, 2025
- Fiscal Year
- 2026
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Fort Worth, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 41 | 21 CFR 606.40(a)(1) | Provide space for examination |
| 9050 | 21 CFR 600.11(a) | Work areas |
| 98 | 21 CFR 606.100(c) | Thorough investigations |