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1205588

AVEM Medical LLC — FEI 3016905952

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 18, 2023
Fiscal Year
2023
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Irving, TX (United States)

Facility

Other inspections at this facility

  • 1097604 (VAI Thu Jul 25 2019 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
1241221 CFR 1271.260(b)Storage temperatures appropriate
126121 CFR 211.68(a)Written calibration / inspection records not kept
434221 CFR 211.142(b)Storage under appropriate conditions