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668740

Temple University Hospital - Jeanes Campus — FEI 2573064

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 18, 2010
Fiscal Year
2010
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Philadelphia, PA (United States)

Facility

Other inspections at this facility

  • 1269365 (NAI Tue Apr 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1121001 (NAI Tue Feb 18 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1035059 (NAI Fri Dec 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 958026 (NAI Tue Jan 12 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 868505 (NAI Thu Feb 27 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
16021 CFR 606.160(a)(1)Person performing, test results, interpretation
16521 CFR 606.170(a)Adverse reaction - Maintenance of Reports
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs