FDA Inspection 913703 — Hunterdon Medical Center Blood Bank
The FDA completed an inspection of Hunterdon Medical Center Blood Bank on February 11, 2015 in Flemington, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 11, 2015
- Fiscal Year
- 2015
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Flemington, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 41 | 21 CFR 606.40(a)(1) | Provide space for examination |
| 43 | 21 CFR 606.40(a)(3) | Provide space for storage of blood & blood products |
| 47 | 21 CFR 606.40(a)(7) | Provide space for collection, processing, testing, dist, etc |
| 51 | 21 CFR 606.40(c) | Provide adequate toilet facilities |