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593220

MedStar Franklin Square Medical Center — FEI 1170456

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 22, 2009
Fiscal Year
2009
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Baltimore, MD (United States)

Facility

Other inspections at this facility

  • 1108990 (NAI Tue Oct 29 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1063782 (NAI Thu Aug 23 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 950876 (NAI Mon Nov 02 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 865188 (NAI Fri Jan 31 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 779195 (NAI Thu Apr 26 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
103321 CFR 211.22(a)Authority lacking to review records, investigate errors
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
922521 CFR 606.171Biological product deviation report