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1266742

Lifesouth Community Blood Centers - Montgomery Region — FEI 3000203326

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 14, 2025
Fiscal Year
2025
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Montgomery, AL (United States)

Facility

Other inspections at this facility

  • 1202935 (NAI Thu Apr 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1098851 (NAI Wed Jul 24 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 983910 (NAI Fri Aug 26 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 888084 (NAI Mon Jul 21 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 754209 (VAI Wed Nov 09 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
22421 CFR 640.4(f)Arm preparation
6521 CFR 606.65(c)Testing of representative samples of reagent lots
6721 CFR 606.65(e)Following manufacturer's instructions
9321 CFR 606.100(b)(14)QC procedures for supplies and reagents
9821 CFR 606.100(c)Thorough investigations