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607300

OneBlood, Inc. — FEI 3005150725

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 10, 2009
Fiscal Year
2009
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Lantana, FL (United States)

Facility

Other inspections at this facility

  • 1268702 (NAI Wed Apr 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1204018 (NAI Fri Apr 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1099888 (NAI Fri Jun 28 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1020009 (NAI Wed Jul 26 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 940684 (NAI Thu Aug 27 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1220321 CFR 606.170(a)Adverse Reaction- Reports of Investigations
15521 CFR 606.160(b)Required records
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs