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838653

National institutes of Health (NIH) Clinical Center — FEI 1174694

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 23, 2013
Fiscal Year
2013
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Bethesda, MD (United States)

Facility

Other inspections at this facility

  • 1259572 (NAI Tue Jan 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1160826 (NAI Wed Dec 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1040752 (NAI Thu Aug 31 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 988673 (NAI Mon Aug 15 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 914710 (VAI Wed Feb 11 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
922521 CFR 606.171Biological product deviation report
923421 CFR 630.40(c)Notification w/in 8 weeks