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1250587

Versiti Blood Health, Inc — FEI 1873403

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 30, 2024
Fiscal Year
2024
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Indianapolis, IN (United States)

Facility

Other inspections at this facility

  • 1088787 (VAI Tue May 07 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1007580 (VAI Fri Mar 17 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 915306 (NAI Wed Feb 25 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 833367 (VAI Fri Apr 19 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 777501 (VAI Tue Apr 10 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1237121 CFR 1271.200(a)Cleaned, sanitized per established schedules
1243121 CFR 1271.265(e)Procedures and release criteria
1243721 CFR 1271.270(a)Records incomplete
15421 CFR 606.160(a)(1)Concurrent documentation
16021 CFR 606.160(a)(1)Person performing, test results, interpretation
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs