FDA Inspection 730681 — Hunterdon Medical Center Blood Bank
The FDA completed an inspection of Hunterdon Medical Center Blood Bank on July 18, 2011 in Flemington, NJ. 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
- July 18, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Flemington, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 4425 | 21 CFR 606.60(a) | Equipment observed, standardized, calibrated |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 78 | 21 CFR 606.100(c) | Record review prior to release |
| 93 | 21 CFR 606.100(b)(14) | QC procedures for supplies and reagents |
| 98 | 21 CFR 606.100(c) | Thorough investigations |