Home / Inspections / 730681

730681

Hunterdon Medical Center Blood Bank — FEI 2273870

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)

Facility

Other inspections at this facility

  • 1261856 (NAI Fri Feb 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1103401 (NAI Fri Sep 20 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1008026 (NAI Wed Apr 05 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 913703 (VAI Wed Feb 11 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 841720 (VAI Thu Jul 25 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
442521 CFR 606.60(a)Equipment observed, standardized, calibrated
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
7821 CFR 606.100(c)Record review prior to release
9321 CFR 606.100(b)(14)QC procedures for supplies and reagents
9821 CFR 606.100(c)Thorough investigations