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1099499

BioDlogics LLC — FEI 3007717495

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 8, 2019
Fiscal Year
2019
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Cordova, TN (United States)

Facility

Other inspections at this facility

  • 1001827 (NAI Fri Jan 27 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 855595 (NAI Tue Nov 05 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 781259 (VAI Fri Apr 27 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 629528 (NAI Tue Nov 17 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1240121 CFR 1271.230(b)Reduced risk representation
1245921 CFR 1271.320(b)Sufficient information to draw conclusions
1246921 CFR 1271.350(a)(1)Adverse reaction reporting to FDA