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573354

Rady Children's Hospital and Health Center — FEI 2077879

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 5, 2009
Fiscal Year
2009
Product Type
Biologics
Project Area
Blood and Blood Products
Location
San Diego, CA (United States)

Facility

Other inspections at this facility

  • 1241097 (NAI Tue May 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1089274 (NAI Wed Mar 27 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1015488 (NAI Tue Jun 06 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 939811 (NAI Fri Aug 14 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 809878 (NAI Fri Dec 07 2012 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
922321 CFR 606.160(b)(6)Required records - transfusion reaction and complaints