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787581

American Natl. Red Cross-Greater Chesapeake & Potomac Region — FEI 1173011

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 10, 2012
Fiscal Year
2012
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Baltimore, MD (United States)

Facility

Other inspections at this facility

  • 1180888 (NAI Mon Sep 12 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1062854 (NAI Thu Jul 26 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 983629 (NAI Thu Sep 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 943997 (VAI Thu Oct 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 895857 (VAI Fri Oct 03 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
121521 CFR 211.67(b)Written procedures not established/followed
16021 CFR 606.160(a)(1)Person performing, test results, interpretation
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
9821 CFR 606.100(c)Thorough investigations