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818344

Asante Rogue Regional Medical Center — FEI 3071140

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 7, 2013
Fiscal Year
2013
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Medford, OR (United States)

Facility

Other inspections at this facility

  • 1238696 (NAI Wed May 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1087623 (NAI Thu Mar 28 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1019446 (VAI Thu Jul 27 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 913613 (NAI Tue Feb 03 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 854469 (VAI Thu Oct 31 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1220321 CFR 606.170(a)Adverse Reaction- Reports of Investigations
16021 CFR 606.160(a)(1)Person performing, test results, interpretation
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