FDA Inspection 1289072 — B Positive National Blood Services - Wilkes Barre, LLC
The FDA completed an inspection of B Positive National Blood Services - Wilkes Barre, LLC on Oct 29, 2025 in Edwardsville, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 29, 2025
- Fiscal Year
- 2026
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Edwardsville, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 53 | 21 CFR 606.40(d)(1) | Provide adequate disposal of trash & discarded items |
| 61 | 21 CFR 606.60(a) | Provide proper equipment to meet requirements |
| 9234 | 21 CFR 630.40(c) | Notification w/in 8 weeks |