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608848

Center For Organ Recovery & Education — FEI 3000719528

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 11, 2009
Fiscal Year
2009
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Pittsburgh, PA (United States)

Facility

Other inspections at this facility

  • 1208722 (NAI Thu Jun 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1014416 (NAI Fri Jun 16 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 938841 (VAI Wed Aug 26 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 835575 (NAI Tue Jun 11 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 722618 (VAI Thu May 12 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1230921 CFR 1271.160(a)Program is appropriate for the HCT/Ps
1232521 CFR 1271.160(b)(6)Deviations--evaluation, cause, corrective action
1233621 CFR 1271.180(a)Procedures to meet core CTGP
1236321 CFR 1271.195(c)Monitoring--cross contamination, exposure to CD
1236921 CFR 1271.200(b)Procedures inadequate
1239821 CFR 1271.230(a)Validation & approval--established procedures
1240521 CFR 1271.250(a)Controlling the labeling of HCT/Ps
1243521 CFR 1271.270(a)Records maintained concurrently
1244821 CFR 1271.290(c)Identification code