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1248317

Inova Health Care Services — FEI 1177788

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 4, 2024
Fiscal Year
2024
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Sterling, VA (United States)

Facility

Other inspections at this facility

  • 1099009 (VAI Wed Aug 07 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1016491 (NAI Fri May 19 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 926576 (NAI Fri Apr 24 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 806318 (VAI Thu Oct 25 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 772364 (VAI Mon Feb 13 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
1503821 CFR 610.47(a)(3)Notify Consignees [Collecting Establishment]
1506721 CFR 610.46(a)(1)(B)Notify Consignees [Collecting Establishment]
1506921 CFR 610.46(a)(3)Notify Consignees [Collecting Establishment]
15421 CFR 606.160(a)(1)Concurrent documentation
1809721 CFR 630.10(h)Ineligible Donor
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
908621 CFR 600.14(a)(1)Who must report - manufacturer