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579026

Stanford Health Care Transfusion Service — FEI 2974539

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 8, 2009
Fiscal Year
2009
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Palo Alto, CA (United States)

Facility

Other inspections at this facility

  • 1267046 (NAI Tue Mar 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1067664 (NAI Thu Sep 20 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 983868 (NAI Tue Jul 26 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 874536 (NAI Thu Apr 17 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 798994 (NAI Fri Sep 14 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
15421 CFR 606.160(a)(1)Concurrent documentation
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
922521 CFR 606.171Biological product deviation report
9821 CFR 606.100(c)Thorough investigations