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934401

American Red Cross Blood Services - Massachusetts Region — FEI 1270026

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 4, 2015
Fiscal Year
2015
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Dedham, MA (United States)

Facility

Other inspections at this facility

  • 1249546 (NAI Fri Sep 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1130057 (NAI Fri Aug 28 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1017552 (VAI Wed May 24 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 850683 (VAI Tue Sep 24 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 775512 (NAI Mon Mar 26 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
121821 CFR 211.67(b)(1)Cleaning SOP/responsibility
15521 CFR 606.160(b)Required records
15921 CFR 606.160(a)(1)Legibility and indelibility
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs