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776722

Genesiscare — FEI 3007009870

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 13, 2012
Fiscal Year
2012
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Naples, FL (United States)

Facility

Other inspections at this facility

  • 1203825 (NAI Tue Apr 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1119798 (VAI Tue Feb 25 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1044785 (VAI Mon Mar 12 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 954425 (VAI Thu Dec 17 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 879728 (VAI Fri May 23 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
15921 CFR 606.160(a)(1)Legibility and indelibility
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
7821 CFR 606.100(c)Record review prior to release
9421 CFR 606.100(b)(15)Schedules and procedures for equipment & calibration