FDA Inspection 1328736 — B Positive National Blood Services - Holmes LLC
The FDA completed an inspection of B Positive National Blood Services - Holmes LLC on Jul 24, 2026 in Holmes, 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
- Jul 24, 2026
- Fiscal Year
- 2026
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Holmes, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 4425 | 21 CFR 606.60(a) | Equipment observed, standardized, calibrated |
| 9234 | 21 CFR 630.40(c) | Notification w/in 8 weeks |
| 9238 | 21 CFR 630.40(b)(3) | Results of testing |