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777775

MedStar Georgetown Medical Center Inc Georgetown University Hospital — FEI 1174826

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 26, 2012
Fiscal Year
2012
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Washington, DC (United States)

Facility

Other inspections at this facility

  • 1234681 (NAI Mon Mar 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1107397 (VAI Tue Sep 10 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1008520 (NAI Fri Mar 24 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 923807 (VAI Mon Apr 27 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 826516 (NAI Tue Apr 09 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
15421 CFR 606.160(a)(1)Concurrent documentation
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
908621 CFR 600.14(a)(1)Who must report - manufacturer
9821 CFR 606.100(c)Thorough investigations