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784663

OneBlood, Inc — FEI 1035139

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 11, 2012
Fiscal Year
2012
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Vero Beach, FL (United States)

Facility

Other inspections at this facility

  • 1262087 (NAI Thu Feb 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1152583 (NAI Wed Sep 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1051870 (NAI Tue Mar 20 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 972178 (NAI Mon May 02 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 883106 (VAI Fri Jun 13 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
20821 CFR 640.3(a)(1)Donor suitability procedures not followed
22721 CFR 640.4(h)Storage temperatures after collection
23821 CFR 640.11(a)General requirements - storage