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1033975

Carter BloodCare — FEI 3002603147

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 6, 2017
Fiscal Year
2018
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Bedford, TX (United States)

Facility

Other inspections at this facility

  • 1217918 (NAI Tue Aug 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1093449 (NAI Fri Apr 12 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 846717 (NAI Thu Aug 29 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 736481 (VAI Wed Jul 27 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 604811 (VAI Mon Aug 17 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
22421 CFR 640.4(f)Arm preparation
37721 CFR 640.120(a)Notification to and approval from CBER
7821 CFR 606.100(c)Record review prior to release
9821 CFR 606.100(c)Thorough investigations