FDA Inspection 1309358 — BioLife Plasma Services L.P.
The FDA completed an inspection of BioLife Plasma Services L.P. on March 20, 2026 in Sacramento, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 20, 2026
- Fiscal Year
- 2026
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Sacramento, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18056 | 21 CFR 630.5(b) | Improper delegation of activities |
| 18070 | 21 CFR 630.10(a) | Donor Eligibility Factors |
| 18118 | 21 CFR 630.30(b)(1) | Unsuitable donation - release |
| 81 | 21 CFR 606.100(b)(2) | Donor qualifying tests & measurements |
| 9243 | 21 CFR 630.40(a) | Notification |