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1097604

AVEM Medical LLC — FEI 3016905952

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 25, 2019
Fiscal Year
2019
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Irving, TX (United States)

Facility

Other inspections at this facility

  • 1205588 (VAI Thu May 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 951524 (VAI Thu Nov 19 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 862062 (VAI Tue Jan 14 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 773842 (NAI Mon Mar 26 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1233621 CFR 1271.180(a)Procedures to meet core CTGP
1234021 CFR 1271.180(d)Adopted from another organization
1241621 CFR 1271.260(e)Storage temperatures recorded, maintained
1244621 CFR 1271.290(a)HCT/Ps not tracked
1245721 CFR 1271.320(a)Procedures re complaints